Salter Labs PRO2PLUS-1
Salter Labs PRO2PLUS-1 is a Class II device made by Salter Labs, LLC, cleared under FDA 510(k) K261389 on 30 Jul 2026 and listed in FDA GUDID since 10 Aug 2026 (UDI-DI 10889483648599), 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 | Number10889483648599 | Date10 Aug 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK261389 | Date30 Jul 2026 | StatusActive |
Official records
- AccessGUDID record 10889483648599
- FDA 510(k) database K261389
Across registries
- FDA 510(k) K261389 decided 30 Jul 2026 Active
- FDA GUDID UDI-DI 10889483648599 listed 10 Aug 2026 Listed
Timeline
- Cleared FDA 510(k) K261389
- Listed FDA GUDID 10889483648599
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Salter Labs
- Generic name
- Respiratory oxygen monitor, battery-powered
- Model / Ref / Catalog
- PRO2PLUS-1
- Primary DI / UDI-DI
- 10889483648599
- 510(k) Number
- FDA product code
- CCL
- GMDN term
- Respiratory oxygen monitor, battery-powered
- Device class
- Class II
- Regulation number
- 868.1720
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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