K242485 is an FDA 510(k) clearance for the EveryWare. This device is classified as a Accessory To Continuous Ventilator (respirator) (Class II - Special Controls, product code MOD).
Submitted by Breas Medical AB (Molnlycke, SE). The FDA issued a Cleared decision on May 20, 2025, 272 days after receiving the submission on August 21, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K242485 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2024 |
| Decision Date | May 20, 2025 |
| Days to Decision | 272 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MOD - Accessory To Continuous Ventilator (respirator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |