AincA® 00-197
by Anesthesia Associates, Inc.
AincA 00-197 is an endotracheal tube cuff inflator (FDA Class II; FDA product code BSK, Cuff, tracheal tube, inflatable) made by Anesthesia Associates, Inc., cleared under FDA 510(k) K912723 on 20 Jul 1991 and listed in FDA GUDID since 31 Mar 2021 (UDI-DI B005001970), 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 | NumberB005001970 | Date31 Mar 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK912723 | Date20 Jul 1991 | StatusActive |
Official records
- FDA 510(k) database K912723
Across registries
- FDA 510(k) K912723 decided 20 Jul 1991 Active
- FDA GUDID UDI-DI B005001970 listed 31 Mar 2021 Listed
Timeline
- Cleared FDA 510(k) K912723
- Listed FDA GUDID B005001970
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AincA®
- Generic name
- Endotracheal tube cuff inflator
- Model / Ref / Catalog
- 00-197
- Primary DI / UDI-DI
- B005001970
- 510(k) Number
- FDA product code
- BSK
- GMDN term
- Endotracheal tube cuff inflator
- Device class
- Class II
- Regulation number
- 868.5750
- GUDID distribution status
- In Commercial Distribution
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