CCL
- Product code
- CCL
- Device name
- Analyzer, Gas, Oxygen, Gaseous-Phase
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.1720
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 122 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261389 | 2026-07-30 | Salter Labs | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) | |
| K251245 | 2025-08-11 | Bio-Med Device, Inc. | OxyMinder Pro (10310) | |
| K250002 | 2025-04-24 | Life Spark Medical, LLC | Smart Check O2 (MA0236) |
Official FDA classification page: CCL
Classification and pathway per current FDA publications. Data from openFDA (CC0).