EveryWare
FDA 510(k) clearance K242485 · decided 2025-05-20
Clearance details
- K-number
- K242485
- Device name
- EveryWare
- Applicant
- Breas Medical AB
- Decision
- Substantially Equivalent
- Date received
- 2024-08-21
- Decision date
- 2025-05-20
- Days to decision
- 272 days
- Clearance type
- Traditional
- Product code
- MOD
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Molnlycke, SE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CorVision® (91-205-Z0014) (K260051) | CorVent® Medical, Inc. | 2026-05-12 |
| Care Cycle Connect Application (K161411) | Respironics, Inc. | 2017-02-17 |
| BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE (K091461) | Cardiopulmonary Corp. | 2009-08-14 |
| VENTLINK SYSTEM (K052751) | Mediserve Information Systems, Inc. | 2005-12-23 |
| IISIS, VERSION 1.0 (K052244) | Innovision Medical Technologies, LLC | 2005-10-13 |
| AIR SAFETY HEPA, MODEL 3500 (K040712) | Air Safety, Ltd. | 2004-06-03 |
| IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 (K022062) | Impact Instrumentation, Inc. | 2003-05-06 |
| TRI-PLEX ADAPTER (K010401) | The Medical Device Group, Inc. | 2002-10-30 |
| BERNOULLI VENTILATOR MANAGEMENT SYSTEM (K011861) | Cardiopulmonary Corp. | 2001-11-06 |
| VENTNET; CENTRAL MONITORING STATION (K963633) | Puritan Bennett Corp. | 1996-12-16 |
| BICORE SMARTCATH INTRATRACHEAL CATHETER (K935788) | Bicore Monitoring Systems | 1995-07-03 |
| VENTILATION MECHANICS MONITOR MODEL VMM-100 (K936156) | Smith Industries Medical Systems (Sims) | 1995-06-27 |
Recalls involving this device
No recalls on record reference this clearance.