SnapshotNIR KD204
SnapshotNIR KD204 is a Class II device made by Kent Imaging Inc, cleared under FDA 510(k) K201976 on 10 Nov 2020 and listed in FDA GUDID since 17 Dec 2020 (UDI-DI B376KD2040), active as of 23 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 | NumberB376KD2040 | Date17 Dec 2020 | StatusListed |
| United States | FDA 510(k) | NumberK201976 | Date10 Nov 2020 | StatusActive |
Official records
- FDA 510(k) database K201976
Across registries
- FDA 510(k) K201976 decided 10 Nov 2020 Active
- FDA GUDID UDI-DI B376KD2040 listed 17 Dec 2020 Listed
Recalls
-
- Ongoing Z-0789-2024
Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.
Timeline
- Cleared FDA 510(k) K201976
- Listed FDA GUDID B376KD2040
- Recall initiated FDA recalls Z-0789-2024
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SnapshotNIR
- Generic name
- Tissue saturation oximeter
- Model / reference
- KD204
- Primary DI / UDI-DI
- B376KD2040
- 510(k) Number
- FDA product code
- MUD
- GMDN term
- Tissue saturation oximeter
- Device class
- Class II
- Regulation number
- 870.2700
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe