CBG CUFF MANOMETER
FDA 510(k) clearance K873614 · decided 1988-01-22
Clearance details
- K-number
- K873614
- Device name
- CBG CUFF MANOMETER
- Applicant
- Bio-Med Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-09-08
- Decision date
- 1988-01-22
- Days to decision
- 136 days
- Clearance type
- Traditional
- Product code
- BSK
- Device class
- 2
- Regulation number
- 868.5750
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Madison, CT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CuffGuard (K243562) | Idmed | 2025-08-12 |
| CuffTrek (K242642) | Shanghai Longmann Tech Co., Ltd. | 2025-03-07 |
| TrachCuff Cuff Controller (K220854) | Aw Technologies Aps | 2023-04-14 |
| AG100s (K221477) | Hospitech Respiration , Ltd. | 2022-12-29 |
| Puritan Bennett Cuff Pressure Manager (K202874) | Covidien, LLC | 2021-01-09 |
| Cuffix (K192611) | Biovo Technologies , Ltd. | 2020-08-13 |
| Pylant Monitor (K191858) | Kal-Med, LLC | 2020-02-24 |
| Accucuff Cuff Pressure Indicator (K182548) | Tianjin Medis Medical Device Co., Ltd. | 2019-01-25 |
| AG 100s (K180991) | Hospitech Respiration , Ltd. | 2018-10-12 |
| VORTRAN Cuff Inflator (VCI) (K173914) | Vortran Medical Technology 1, Inc. | 2018-05-25 |
| TRACOE Cuff Pressure Monitor (K152778) | Tracoe Medical GmbH | 2016-12-21 |
| TRACOE smart Cuff Manager (K152865) | Tracoe Medical GmbH | 2016-09-27 |
Recalls involving this device
No recalls on record reference this clearance.