All Flow 5554100
All Flow 5554100 is a pulmonary function testing kit (FDA Class II; FDA product code CAH, Filter, Bacterial, Breathing-Circuit) made by Alliance Tech Medical Inc, cleared under FDA 510(k) K043148 on 13 Dec 2004 and listed in FDA GUDID since 26 Sep 2016 (UDI-DI 00384620000023), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00384620000023 | Date26 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK043148 | Date13 Dec 2004 | StatusActive |
Official records
- AccessGUDID record 00384620000023
- FDA 510(k) database K043148
Across registries
- FDA 510(k) K043148 decided 13 Dec 2004 Active
- FDA GUDID UDI-DI 00384620000023 listed 26 Sep 2016 Listed
Recalls
-
- Completed Z-0714-2020
Patients have experienced a bad taste associated with the filters.
Timeline
- Cleared FDA 510(k) K043148
- Recall initiated FDA recalls Z-0714-2020
- Listed FDA GUDID 00384620000023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- All Flow
- Generic name
- Pulmonary function testing kit
- Model / reference
- 5554100
- Primary DI / UDI-DI
- 00384620000023
- 510(k) Number
- FDA product code
- CAH
- GMDN term
- Pulmonary function testing kit
- Device class
- Class II
- Regulation number
- 868.5260
- GUDID distribution status
- In Commercial Distribution
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