COSMED Pony FX Flowsafe
COSMED Pony FX Flowsafe is a Class II device made by C O S M E D SRL, cleared under FDA 510(k) K040549 on 28 Sep 2004 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 18052400180058), 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 | Number18052400180058 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK040549 | Date28 Sep 2004 | StatusActive |
Official records
- AccessGUDID record 18052400180058
- FDA 510(k) database K040549
Across registries
- FDA 510(k) K040549 decided 28 Sep 2004 Active
- FDA GUDID UDI-DI 18052400180058 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K040549
- Listed FDA GUDID 18052400180058
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cosmed
- Generic name
- Diagnostic spirometer, professional
- Model / reference
- Pony FX Flowsafe
- Primary DI / UDI-DI
- 18052400180058
- 510(k) Number
- FDA product code
- DQA, BTY
- GMDN term
- Diagnostic spirometer, professional
- Device class
- Class II
- Regulation number
- 870.2700, 868.1890
- GUDID distribution status
- In Commercial Distribution
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