FondCircle M1-S50
FondCircle M1-S50 is a Class II device made by FondCircle Inc., cleared under FDA 510(k) K191657 on 20 Mar 2020 and listed in FDA GUDID since 18 Mar 2025 (UDI-DI 00850070979252), active as of 22 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 | Number00850070979252 | Date18 Mar 2025 | StatusListed |
| United States | FDA 510(k) | NumberK191657 | Date20 Mar 2020 | StatusActive |
Official records
- AccessGUDID record 00850070979252
- FDA 510(k) database K191657
Across registries
- FDA 510(k) K191657 decided 20 Mar 2020 Active
- FDA GUDID UDI-DI 00850070979252 listed 18 Mar 2025 Listed
Timeline
- Cleared FDA 510(k) K191657
- Listed FDA GUDID 00850070979252
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- FondCircle
- Generic name
- Glucose monitoring system IVD, home-use
- Model / reference
- M1-S50
- Primary DI / UDI-DI
- 00850070979252
- 510(k) Number
- FDA product code
- NBW
- GMDN term
- Glucose monitoring system IVD, home-use
- Device class
- Class II
- Regulation number
- 862.1345
- GUDID distribution status
- In Commercial Distribution
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