K242769 is an FDA 510(k) clearance for the VentStar Resus heated (N) (MP17030). This device is classified as a Ventilator, Emergency, Powered (resuscitator) (Class II - Special Controls, product code BTL).
Submitted by Draegerwerk AG & CO Kgaa (Luebeck, DE). The FDA issued a Cleared decision on April 4, 2025, 203 days after receiving the submission on September 13, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5925.
| 510(k) Number | K242769 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 2024 |
| Decision Date | April 04, 2025 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTL - Ventilator, Emergency, Powered (resuscitator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5925 |