McKesson 16-VOL5000
by Mckesson Medical-Surgical Inc.
McKesson 16-VOL5000 is a Class II device made by Mckesson Medical-Surgical Inc., cleared under FDA 510(k) K141355 on 3 Sep 2014 and listed in FDA GUDID since 14 May 2024 (UDI-DI 10612479269900), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10612479269900 | Date14 May 2024 | StatusListed |
| United States | FDA 510(k) | NumberK141355 | Date3 Sep 2014 | StatusActive |
Official records
- AccessGUDID record 10612479269900
- FDA 510(k) database K141355
Across registries
- FDA 510(k) K141355 decided 3 Sep 2014 Active
- FDA GUDID UDI-DI 10612479269900 listed 14 May 2024 Listed
Timeline
- Cleared FDA 510(k) K141355
- Listed FDA GUDID 10612479269900
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- McKesson
- Generic name
- Incentive spirometer
- Model / reference
- 16-VOL5000
- Primary DI / UDI-DI
- 10612479269900
- 510(k) Number
- FDA product code
- BWF
- GMDN term
- Incentive spirometer
- Device class
- Class II
- Regulation number
- 868.5690
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code BWF (Spirometer, Therapeutic (Incentive)).
- Breathe+ by Peep Medical, LLC Dba Go2 Devices
- ARGYLE TRU-VOL by Sherwood Medical Co.
- AMBU RMT VALVE by Ambu, Inc.
- RESPIREX 2 by Diemolding Corp.
- CLINIFLO INCENTIVE SPIROMETER by Dhd Healthcare Corp.
- EXERCISER, RESP., DEEP BREATHING by Medical Technologies of Georgia
- THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER by Health Products, Inc.
- VibraPEP by Medica Holdings, LLC
- LUNG EXER. BAG, POST-OP, MODIFIED by Dytek Corp.
- LUNG TECHNOLOGIES 5000 THERAPEUTIC INCENTIVE SPIROMETER by Lung Technologies, Inc.