PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)
510(k) K261389
PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) is a Class II device made by Salter Labs, LLC, cleared under FDA 510(k) K261389 on 30 Jul 2026, 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 | FDA 510(k)SESE | NumberK261389 | Date30 Jul 2026 | StatusActive |
Official records
- FDA 510(k) database K261389
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CCL
- FDA applicant
- Salter Labs
- Device class
- Class II
- Regulation
- 21 CFR Part 868.1720
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
From the manufacturer
Manufacturer's product page: PRO2 Elite Plus™ Oxygen Analyzer
Devices cleared under K261389
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Salter Labs PRO2PLUS-1 | PRO2PLUS-1 / PRO2PLUS-1 | 10889483648599 | — | On the market |
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