K251216 is an FDA 510(k) clearance for the 0184 CO2 Sampling line. This device is classified as a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II - Special Controls, product code CCK).
Submitted by Barbaras Development, Inc. (Newbury Park, US). The FDA issued a Cleared decision on June 4, 2025, 47 days after receiving the submission on April 18, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1400.
| 510(k) Number | K251216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2025 |
| Decision Date | June 04, 2025 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CCK - Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1400 |