Compact FM 60130T
by Avante
Compact FM 60130T is a Class II device made by Avante, cleared under FDA 510(k) K150901 on 1 Jul 2015 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00815871020213), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00815871020213 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK150901 | Date1 Jul 2015 | StatusActive |
Official records
- AccessGUDID record 00815871020213
- FDA 510(k) database K150901
Across registries
- FDA 510(k) K150901 decided 1 Jul 2015 Active
- FDA GUDID UDI-DI 00815871020213 listed 23 Sep 2016 Listed
Recalls
-
- Ongoing Z-1141-2026
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Timeline
- Cleared FDA 510(k) K150901
- Listed FDA GUDID 00815871020213
- Recall initiated FDA recalls Z-1141-2026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Compact FM
- Generic name
- Foetal cardiac monitor
- Model / reference
- 60130T
- Primary DI / UDI-DI
- 00815871020213
- 510(k) Number
- FDA product code
- HGM
- GMDN term
- Foetal cardiac monitor
- Device class
- Class II
- Regulation number
- 884.2740
- GUDID distribution status
- In Commercial Distribution