K242909 is an FDA 510(k) clearance for the FloTrac sensors. This device is classified as a Transducer, Blood-pressure, Extravascular (Class II - Special Controls, product code DRS).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on March 21, 2025, 178 days after receiving the submission on September 24, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2850.
| 510(k) Number | K242909 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2024 |
| Decision Date | March 21, 2025 |
| Days to Decision | 178 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRS — Transducer, Blood-pressure, Extravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2850 |