FDA Product Code
FDA Product Code BSK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.5750
510(k) Clearances — 40 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261499 | TrachFlush | Aw Technologies Aps | 2026-08-13 | Traditional | PDF ↗ |
| K243562 | CuffGuard | Idmed | 2025-08-12 | Traditional | PDF ↗ |
| K242642 | CuffTrek | Shanghai Longmann Tech Co., Ltd. | 2025-03-07 | Traditional | PDF ↗ |
| K220854 | TrachCuff Cuff Controller | Aw Technologies Aps | 2023-04-14 | Traditional | PDF ↗ |
| K221477 | AG100s | Hospitech Respiration , Ltd. | 2022-12-29 | Traditional | PDF ↗ |
| K202874 | Puritan Bennett Cuff Pressure Manager | Covidien, LLC | 2021-01-09 | Traditional | PDF ↗ |
| K192611 | Cuffix | Biovo Technologies , Ltd. | 2020-08-13 | Traditional | PDF ↗ |
| K191858 | Pylant Monitor | Kal-Med, LLC | 2020-02-24 | Traditional | PDF ↗ |
| K182548 | Accucuff Cuff Pressure Indicator | Tianjin Medis Medical Device Co., Ltd. | 2019-01-25 | Traditional | PDF ↗ |
| K180991 | AG 100s | Hospitech Respiration , Ltd. | 2018-10-12 | Traditional | PDF ↗ |
| K173914 | VORTRAN Cuff Inflator (VCI) | Vortran Medical Technology 1, Inc. | 2018-05-25 | Traditional | PDF ↗ |
| K152778 | TRACOE Cuff Pressure Monitor | Tracoe Medical GmbH | 2016-12-21 | Traditional | PDF ↗ |
| K152865 | TRACOE smart Cuff Manager | Tracoe Medical GmbH | 2016-09-27 | Traditional | PDF ↗ |
| K150157 | AnapnoGuard 100 Respiratory Guard System | Hospitech Respiration , Ltd. | 2016-02-16 | Traditional | PDF ↗ |
| K150893 | IntelliCuff | Hamilton Medical AG | 2016-01-29 | Traditional | PDF ↗ |
| K142103 | CUFF PILOT, SURE SEAL | Teleflexmedical, Inc. | 2015-05-08 | Traditional | PDF ↗ |
| K122721 | AG GUFFILL | Hospitech Respiration , Ltd. | 2013-05-03 | Traditional | PDF ↗ |
| K112915 | SPIRTIUS CUFF INFLATION SYRINGE | Spiritus Technologies, LLC | 2012-05-25 | Traditional | PDF ↗ |
| K113644 | PILOT TUBE REPAIR KIT | Instrumentation Industries, Inc. | 2012-01-26 | Special | PDF ↗ |
| K110631 | VENNER TRACHEAL SEAL MONITOR | Venner Medical (Singapore) Pte, Ltd. | 2011-07-28 | Traditional | PDF ↗ |
| K102674 | CUFF SENTRY | Ventlab Corp. | 2011-07-22 | Traditional | PDF ↗ |
| K102704 | EASY CUFF | Joan Spiegel, MD | 2011-03-10 | Traditional | PDF ↗ |
| K092733 | PYTON | Arm Medical Devices, Inc. | 2010-02-26 | Traditional | PDF ↗ |
| K081805 | CUFFALERT | Sunmed | 2008-11-14 | Traditional | PDF ↗ |
| K973755 | PILOT TUBE REPAIR KIT | Instrumentation Industries, Inc. | 1997-12-17 | Traditional | PDF ↗ |
| K951046 | RUSCH ENDOTEST CUFF PRESSURE MONITOR | Rusch Intl. | 1995-04-06 | Traditional | PDF ↗ |
| K923800 | PRESSURE GAUGE | Innovations For Mechanical Ventilation, Inc. | 1993-02-26 | Traditional | PDF ↗ |
| K912352 | PEACE MODEL 100 CUFF MONITOR | Peace Medical, Inc. | 1991-08-02 | Traditional | PDF ↗ |
| K912723 | POSEY CUFFLATOR | Posey Co. | 1991-07-20 | Traditional | PDF ↗ |
| K902114 | CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR | Diemolding Corp. | 1990-07-18 | Traditional | PDF ↗ |
| K900755 | DIGITAL CUFF PV GAUGE | International Medical Products, Inc. | 1990-04-26 | Traditional | PDF ↗ |
| K901255 | CUFF BARO GUARD OR CBG ABBREVIATED | Nelson Engineering, Inc. | 1990-03-28 | Traditional | PDF ↗ |
| K885216 | ATTACHABLE LANZ (TENTATIVE) | Mallinckroot, Inc. | 1989-03-14 | Traditional | PDF ↗ |
| K884638 | BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR | Instrumentation Industries, Inc. | 1988-11-23 | Traditional | PDF ↗ |
| K881514 | PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM | Hall Laboratories, Inc. | 1988-06-16 | Traditional | PDF ↗ |
| K881178 | CUFFCHECK | Dhd Medical Products Div. Diemolding Corp. | 1988-04-14 | Traditional | PDF ↗ |
| K873614 | CBG CUFF MANOMETER | Bio-Med Devices, Inc. | 1988-01-22 | Traditional | PDF ↗ |
| K833327 | RESPIRONICS PR VALVE | Respironics, Inc. | 1983-11-28 | Traditional | PDF ↗ |
| K831577 | TRACHEA/CUFF INFLATOR W/PRESSURE #583 | Medical Electronics Corp. | 1983-07-07 | Traditional | PDF ↗ |
| K792265 | SHILEY PRESSURE RELIEF ADAPTER PRA | Shiley, Inc. | 1979-11-27 | Traditional | PDF ↗ |
Product code BSK · Class II · Anesthesiology. Data: openFDA.