PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)— 510(k) K261389
Substantially EquivalentSalter Labs
FDA 510(k) clearance K261389 for PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1), Substantially Equivalent on 2026-07-30. Applicant: Salter Labs. Device class: 2.
Summary
Salter Labs' PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) is filed under CCL, gaseous-phase oxygen gas analyzers. The record gives the model as PRO2PLUS-1 but no specs.
Class II, 21 CFR 868.1720. Anesthesiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Salter Labs filed from El Paso, Texas. Review took 93 calendar days (April 28 to July 30, 2026).
Clearance details
- Applicant
- Salter Labs
- Product code
- Product code CCL
- Device class
- Class 2
- Regulation
- 21 CFR 868.1720
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- El Paso, TX, US
Recent devices under product code CCL
view allMore clearances from Salter Labs
view all- K161719 — Salter Labs Bubble Humidifier
- K151874 — BiNAPS Nasal Airflow and Snore Transducer +1 more
- K151506 — Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
- K151421 — Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines
- K143700 — CPAP Cannulaide
Adverse events under product code CCL
product code CCL- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.