FDA Product Code
FDA Product Code FMK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4850
510(k) Clearances — 111 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262526 | Safety lancet (XL) | Tianjin Huahong Technology Co., Ltd. | 2026-09-13 | Traditional | PDF ↗ |
| K261045 | Verifine Safety Lancets | Promisemed Hangzhou Meditech Co., Ltd. | 2026-05-01 | Special | PDF ↗ |
| K260191 | Safety lancet (XXXVII) | Tianjin Huahong Technology Co., Ltd. | 2026-03-31 | Traditional | PDF ↗ |
| K253605 | Safety Heel Lancet | Ningbo Medsun Medical Co., Ltd. | 2026-02-20 | Traditional | PDF ↗ |
| K252490 | Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) | Tianjin Huahong Technology Co., Ltd. | 2026-02-12 | Special | PDF ↗ |
| K251694 | safety lancet | Tianjin Huahong Technology Co., Ltd. | 2025-06-26 | Special | PDF ↗ |
| K244036 | Heel Incision Safety Lancet (SteriHeel 2) | SteriLance Medical (Suzhou), Inc. | 2025-02-26 | Traditional | PDF ↗ |
| K243533 | Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus | Hlb Co., Ltd. Healthcare | 2025-01-13 | Traditional | PDF ↗ |
| K242680 | LetsGetChecked Impress | Privapath Diagnostics Ltd (Dba Letsgetchecked) | 2025-01-13 | Traditional | PDF ↗ |
| K242664 | gentleheel® Adult Incision Device | Gri-Alleset, Inc. | 2024-11-05 | Traditional | PDF ↗ |
| K242627 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | 2024-10-30 | Traditional | PDF ↗ |
| K242316 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | 2024-08-28 | Special | PDF ↗ |
| K241848 | MedtFine Safety Lancet | Ningbo Caremed Medical Products Co., Ltd. | 2024-08-20 | Traditional | PDF ↗ |
| K241750 | Medifun Safety Lancet ( MSL1 series) | Medifun Corporation | 2024-08-15 | Traditional | PDF ↗ |
| K241627 | Safety Lancet (XXXV) | Tianjin Huahong Technology Co., Ltd. | 2024-06-20 | Traditional | PDF ↗ |
| K240806 | Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.) | Tianjin Huahong Technology Co., Ltd. | 2024-05-21 | Traditional | PDF ↗ |
| K234081 | RedDrop ONE (One) | Reddrop DX | 2024-03-21 | Traditional | PDF ↗ |
| K223826 | NanoDrop Lancet | Drawbridge Health, Inc. | 2024-02-22 | Traditional | PDF ↗ |
| K233796 | Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro) | SteriLance Medical (Suzhou), Inc. | 2024-01-16 | Traditional | PDF ↗ |
| K232509 | Accu-Chek Safe-T-Pro Uno Lancing Device | Roche Diabetes Care, Inc. | 2023-11-13 | Traditional | PDF ↗ |
| K232488 | Accu-Chek Safe-T-Pro Plus Lancing Device | Roche Diabetes Care, Inc. | 2023-11-13 | Traditional | PDF ↗ |
| K231124 | Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) | Owen Mumford, Ltd. | 2023-06-27 | Traditional | PDF ↗ |
| K223201 | TAP Lancet | Yourbio Health, Inc. | 2023-04-19 | Traditional | PDF ↗ |
| K223352 | Tenderfoot | Accriva Diagnostics, Inc. | 2023-03-02 | Special | PDF ↗ |
| K223900 | babyLance Safety Heelstick (BLM, BLN, BLP) | Clinical Innovations, LLC | 2023-02-24 | Traditional | PDF ↗ |
| K223370 | NeatNick Heel Safety Lancet | Facet Technologies, LLC | 2023-02-13 | Traditional | PDF ↗ |
| K223208 | Safety Lancet | Suzhou Zhenwu Medical Co., Ltd. | 2023-02-10 | Traditional | PDF ↗ |
| K222801 | Safety Lancet | Sarstedt AG & CO KG | 2023-01-25 | Traditional | PDF ↗ |
| K223313 | Disposable Safety Lancets | Huaian Hening Medical Instruments Co., Ltd. | 2023-01-23 | Traditional | PDF ↗ |
| K223243 | BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel Lancets | Becton, Dickinson and Company | 2022-12-16 | Traditional | PDF ↗ |
| K222408 | Disposable Safety Lancet | Beijing Ruicheng Medical Supplies Co., Ltd. | 2022-11-29 | Traditional | PDF ↗ |
| K222055 | Disposable Sterile Lancet | Tianjin Rilifine Medical Device Co., Ltd. | 2022-11-15 | Traditional | PDF ↗ |
| K222168 | Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler | Owen Mumford, Ltd. | 2022-11-03 | Traditional | PDF ↗ |
| K222084 | OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie | Asahi Polyslider Co., Ltd. | 2022-11-02 | Traditional | PDF ↗ |
| K221521 | Disposable Safety Lancet | SteriLance Medical (Suzhou), Inc. | 2022-10-28 | Traditional | PDF ↗ |
| K222303 | Unistik® Pro | Owen Mumford, Ltd. | 2022-10-25 | Traditional | PDF ↗ |
| K221783 | SafetiCET Safety Lancet | Nsp Tech Pte, Ltd. | 2022-10-24 | Traditional | PDF ↗ |
| K221778 | Disposable Safety Lancets | Suzhou Kyuan Medical Apparatus Co., Ltd. | 2022-10-03 | Traditional | PDF ↗ |
| K222376 | Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) | Shandong Lianfa Medical Plastic Products Co. , Ltd. | 2022-10-03 | Traditional | PDF ↗ |
| K222090 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | 2022-09-30 | Traditional | PDF ↗ |
| K222224 | SurgiLance® Safety Lancet | Medipurpose Pte. , Ltd. | 2022-09-22 | Traditional | PDF ↗ |
| K221839 | Lancet | Hebei Xinle Sci&Tech Co., Ltd. | 2022-09-19 | Traditional | PDF ↗ |
| K222111 | Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G | Owen Mumford, Ltd. | 2022-09-07 | Traditional | PDF ↗ |
| K221604 | SafetiHeel, MediHeel, Novaplus | Nsp Tech Pte, Ltd. | 2022-08-22 | Traditional | PDF ↗ |
| K221131 | Tasso+ | Tasso, Inc. | 2022-08-12 | Traditional | PDF ↗ |
| K221126 | Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets | Owen Mumford, Ltd. | 2022-08-12 | Traditional | PDF ↗ |
| K220643 | DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets | Htl-Strefa S.A | 2022-07-08 | Traditional | PDF ↗ |
| K221368 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet | Promisemed Hangzhou Meditech Co., Ltd. | 2022-06-09 | Special | PDF ↗ |
| K221371 | Promisemed Heel Blood Lancet | Promisemed Hangzhou Meditech Co., Ltd. | 2022-06-08 | Special | PDF ↗ |
| K220370 | Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) | Tianjin Huahong Technology Co., Ltd. | 2022-05-19 | Traditional | PDF ↗ |
| K220849 | Accu-Chek Safe-T-Pro Plus Lancing Device | Roche Diabetes Care, Inc. | 2022-05-19 | Traditional | PDF ↗ |
| K220917 | gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler | Gri-Alleset, Inc. | 2022-05-18 | Traditional | PDF ↗ |
| K220372 | Heel Stick Safety Lancet (HHZ-II, HHZ-III) | Tianjin Huahong Technology Co., Ltd. | 2022-05-17 | Traditional | PDF ↗ |
| K220364 | Accu-Chek Safe-T-Pro Uno Lancing Device | Roche Diabetes Care, Inc. | 2022-04-05 | Traditional | PDF ↗ |
| K210745 | Heel Incision Safety Lancet | SteriLance Medical (Suzhou), Inc. | 2021-08-26 | Traditional | PDF ↗ |
| K193009 | Promisemed Heel Blood Lancet | Promisemed Hangzhou Meditech Co., Ltd. | 2019-12-03 | Traditional | PDF ↗ |
| K192666 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet | Promisemed Hangzhou Meditech Co., Ltd. | 2019-12-02 | Traditional | PDF ↗ |
| K172712 | gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler | Gri Medical & Electronic Technology Co., Ltd. | 2017-11-06 | Traditional | PDF ↗ |
| K153670 | Genteel Lancing Device | Genteel, LLC | 2016-05-12 | Traditional | PDF ↗ |
| K130132 | BABYLANCE HEEL INCISION DEVICE | Medipurpose Pte. , Ltd. | 2013-02-11 | Special | PDF ↗ |
| K113513 | PLANCET | Micropoint Technologies Pte, Ltd. | 2012-07-13 | Traditional | PDF ↗ |
| K113332 | ON CALL CHOSEN LANCING DEVICE | ACON Laboratories, Inc. | 2012-04-18 | Abbreviated | PDF ↗ |
| K101145 | SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 | Medipurpose Pte. , Ltd. | 2010-10-21 | Abbreviated | PDF ↗ |
| K101417 | BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200 | Medipurpose Pte. , Ltd. | 2010-10-19 | Abbreviated | PDF ↗ |
| K041665 | L1-PRO SYSTEM | Pelikan Technologies, Inc. | 2004-07-23 | Traditional | PDF ↗ |
| K024170 | L1 SYSTEM | Pelikan Technologies, Inc. | 2003-04-14 | Traditional | PDF ↗ |
| K001162 | GOLDFINGER DEVICE | Mali-Tech , Ltd. | 2000-08-09 | Traditional | PDF ↗ |
| K944948 | FREE-LANCE | F.F.F. Enterprises, Inc. | 1994-11-17 | Traditional | PDF ↗ |
| K942548 | JENNINGS JAVELIN | Jfi Endineering, Inc. | 1994-11-03 | Traditional | PDF ↗ |
| K942620 | FEATHER-TOUCH SINGLE-STICK DEVICE | Ulster Scientific, Inc. | 1994-06-22 | Traditional | PDF ↗ |
| K931258 | SOFTTOUCH II LANCET DEVICE | Boehringer Mannheim Corp. | 1994-02-10 | Traditional | PDF ↗ |
| K933365 | BABISTICK | Graphic Controls Corp. | 1993-10-19 | Traditional | PDF ↗ |
| K931828 | CARELET SAFETY LANCET | Gainor Medical Europe, Ltd. | 1993-10-15 | Traditional | PDF ↗ |
| K931481 | MINI-LANCET | Pacific Rim Products, Inc. | 1993-10-01 | Traditional | PDF ↗ |
| K932785 | MONOJECT(R) MONOLETTOR SAFETY LANCET | Sherwood Medical Co. | 1993-09-29 | Traditional | PDF ↗ |
| K931827 | CLEANLET, CLEANLET XL & KIDS | Gainor Medical Europe, Ltd. | 1993-09-13 | Traditional | PDF ↗ |
| K932725 | B-D ULTRA FINE(R) LANCET | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993-07-23 | Traditional | PDF ↗ |
| K923302 | TENDERLETT FINGER | International Technidyne Corp. | 1993-01-22 | Traditional | PDF ↗ |
| K920562 | UNISTIK | Ulster Scientific, Inc. | 1992-03-27 | Traditional | PDF ↗ |
| K911997 | TENDERFOOT(R), MODIFICATION | International Technidyne Corp. | 1991-07-17 | Traditional | PDF ↗ |
| K902430 | GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD | Heraeus Kulzer, Inc. | 1990-08-02 | Traditional | PDF ↗ |
| K902416 | SURELITE AND SURELITE XL BLOOD LANCET | Gainor Medical Europe, Ltd. | 1990-08-01 | Traditional | PDF ↗ |
| K894427 | DISPOSABLE IV INDUCTION COVER | Central Plastic, Inc. | 1989-09-11 | Traditional | PDF ↗ |
| K894474 | THE AUTOLET LITE | Ulster Scientific, Inc. | 1989-08-18 | Traditional | PDF ↗ |
| K885342 | GENNY DENNY IV SHIELD | Mercury Enterprises, Inc. | 1989-03-30 | Traditional | PDF ↗ |
| K883968 | TENDERFOOT | International Technidyne Corp. | 1988-12-01 | Traditional | PDF ↗ |
| K883957 | ARTERIAL ANCHOR BANDAGE | Guidelines, Inc. | 1988-10-18 | Traditional | PDF ↗ |
| K883420 | LANCET, BLOOD | Primrose Medical, Inc. | 1988-08-26 | Traditional | PDF ↗ |
| K880869 | MEDI-LET | Medicore, Inc. | 1988-03-21 | Traditional | PDF ↗ |
| K850100 | BLOOD LANCET | Gainor Medical | 1987-01-29 | Traditional | PDF ↗ |
| K870017 | AMG + MED LANCET | Can-Am Surgical Corp. | 1987-01-21 | Traditional | PDF ↗ |
| K865016 | BLOOD LANCET | Falcon Medical Industries, Inc. | 1987-01-12 | Traditional | PDF ↗ |
| K863621 | PALS | West Lake Marketing | 1986-10-06 | Traditional | PDF ↗ |
| K861265 | DIALET LANCING DEVICE | Home Diagnostics, Inc. | 1986-04-30 | Traditional | PDF ↗ |
| K861243 | NEONATAL UNILET | Ulster Scientific, Inc. | 1986-04-29 | Traditional | PDF ↗ |
| K861151 | SUEL BLOOD LANCET | Exel Intl. | 1986-04-15 | Traditional | PDF ↗ |
| K855203 | GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD | Miles Laboratories, Inc. | 1986-02-11 | Traditional | PDF ↗ |
| K854760 | CHURCHHILL LANCET | Churchill Corp. | 1986-01-03 | Traditional | PDF ↗ |
| K850150 | ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED | Gainor Medical | 1985-02-21 | Traditional | PDF ↗ |
| K841677 | STERILE BLOOD LANCETS | Abco Dealers, Inc. | 1984-06-11 | Traditional | PDF ↗ |
Product code FMK · Class II · General, Plastic Surgery. Data: openFDA.