FDA Product Code
FDA Product Code QRL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4850
510(k) Clearances — 27 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262135 | Lancing device | Tianjin Huahong Technology Co., Ltd. | 2026-08-18 | Traditional | PDF ↗ |
| K262211 | Lancet | Tianjin Huahong Technology Co., Ltd. | 2026-07-22 | Special | PDF ↗ |
| K260122 | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) | SteriLance Medical (Suzhou), Inc. | 2026-07-06 | Traditional | PDF ↗ |
| K253706 | Lancing device (HH-XV-T) | Tianjin Huahong Technology Co., Ltd. | 2025-12-09 | Special | PDF ↗ |
| K250813 | MICROLET®NEXT 2 Lancing Device | Ascensia Diabetes Care U.S., Inc. | 2025-05-14 | Traditional | PDF ↗ |
| K243306 | Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) | Tianjin Huahong Technology Co., Ltd. | 2024-11-15 | Special | PDF ↗ |
| K232912 | Facet Aurora Reusable Lancet Base | Facet Technologies, LLC | 2024-01-25 | Traditional | PDF ↗ |
| K231797 | Medifun Lancing Device, Model No. LD-E1 | Medifun Corporation | 2023-11-22 | Traditional | PDF ↗ |
| K223643 | Verifine® Ease Lancing Device, Verifine® Lancing Device | Promisemed Hangzhou Meditech Co., Ltd. | 2023-02-21 | Traditional | PDF ↗ |
| K221419 | TD-5010 Lancing Device and TD-5084 Sterile Lancets | Gostar Co., Ltd. | 2023-01-20 | Traditional | PDF ↗ |
| K222472 | Lancing System, Sterile Lancet for Single Use, Lancing Device | Shandong Lianfa Medical Plastic Products Co. , Ltd. | 2022-11-30 | Traditional | PDF ↗ |
| K223099 | Facet Manatee Reusable Lancing Base | Facet Technologies, LLC | 2022-11-28 | Traditional | PDF ↗ |
| K222656 | LDE4 Lancing Device | I-Sens, Inc. | 2022-11-23 | Traditional | PDF ↗ |
| K222246 | Disposable Sterile Lancet | Tianjin Rilifine Medical Device Co., Ltd. | 2022-11-21 | Traditional | PDF ↗ |
| K222539 | Facet Blood Lancets | Facet Technologies, LLC | 2022-11-18 | Traditional | PDF ↗ |
| K221072 | TRUEdraw Lancing Device, Mini Lancing Device | Trividia Health | 2022-10-18 | Traditional | PDF ↗ |
| K221175 | Multi-Lancet Device 2, ReliOn Premier Lancing Device | Arkray, Inc. | 2022-10-17 | Traditional | PDF ↗ |
| K221613 | Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets | Owen Mumford, Ltd. | 2022-10-03 | Traditional | PDF ↗ |
| K221062 | RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device | Bionime Corporation | 2022-09-26 | Traditional | PDF ↗ |
| K222034 | RightLance Blood Lancing System | Beijing Ruicheng Medical Supplies Co., Ltd. | 2022-09-07 | Traditional | PDF ↗ |
| K221970 | Lancing device | SteriLance Medical (Suzhou), Inc. | 2022-08-30 | Traditional | PDF ↗ |
| K221546 | OneTouch Delica Plus Lancing System | Asahi Polyslider Co., Ltd. | 2022-08-23 | Traditional | PDF ↗ |
| K220387 | Disposable Blood Lancets | Suzhou Kyuan Medical Apparatus Co., Ltd. | 2022-08-17 | Traditional | PDF ↗ |
| K220475 | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) | Tianjin Huahong Technology Co., Ltd. | 2022-07-06 | Traditional | PDF ↗ |
| K220633 | MICROLET NEXT lancing device, MICROLET Lancet | Ascensia Diabetes Care U.S., Inc. | 2022-06-03 | Traditional | PDF ↗ |
| K220608 | Accu-Chek FastClix Blood Lancing System | Roche Diabetes Care, Inc. | 2022-04-29 | Traditional | PDF ↗ |
| K214022 | Accu-Chek Softclix Blood Lancing System | Roche Diabetes Care, Inc. | 2022-02-17 | Traditional | PDF ↗ |
Product code QRL · Class II · General, Plastic Surgery. Data: openFDA.