Rd 9992
Rd 9992 is a Class II device made by Masimo Corporation, cleared under FDA 510(k) K180046 on 23 Oct 2018 and listed in FDA GUDID since 16 Mar 2022 (UDI-DI 00843997016001), 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 | Number00843997016001 | Date16 Mar 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180046 | Date23 Oct 2018 | StatusActive |
Official records
- AccessGUDID record 00843997016001
- FDA 510(k) database K180046
Across registries
- FDA 510(k) K180046 decided 23 Oct 2018 Active
- FDA GUDID UDI-DI 00843997016001 listed 16 Mar 2022 Listed
Recalls
-
- Ongoing Z-1983-2023
TC-I tip clip sensor may produce readings outside the accuracy specification.
Timeline
- Cleared FDA 510(k) K180046
- Listed FDA GUDID 00843997016001
- Recall initiated FDA recalls Z-1983-2023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Rd
- Generic name
- Pulse oximeter probe, single-use
- Model / reference
- 9992
- Primary DI / UDI-DI
- 00843997016001
- 510(k) Number
- FDA product code
- DQA
- GMDN term
- Pulse oximeter probe, single-use
- Device class
- Class II
- Regulation number
- 870.2700
- GUDID distribution status
- In Commercial Distribution
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