McKesson 16-VOL2500
by Mckesson Medical-Surgical Inc.
McKesson 16-VOL2500 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 10612479269924), 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 | Number10612479269924 | Date14 May 2024 | StatusListed |
| United States | FDA 510(k) | NumberK141355 | Date3 Sep 2014 | StatusActive |
Official records
- AccessGUDID record 10612479269924
- FDA 510(k) database K141355
Across registries
- FDA 510(k) K141355 decided 3 Sep 2014 Active
- FDA GUDID UDI-DI 10612479269924 listed 14 May 2024 Listed
Timeline
- Cleared FDA 510(k) K141355
- Listed FDA GUDID 10612479269924
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- McKesson
- Generic name
- Incentive spirometer
- Model / reference
- 16-VOL2500
- Primary DI / UDI-DI
- 10612479269924
- 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
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