Care-e-vac EMS - Reusable jar
by Hersill Sl
Care-e-vac EMS - Reusable jar (5320216) is an emergency airway clearance suction system (FDA Class II; FDA product code BTA, Pump, Portable, Aspiration (Manual Or Powered)) made by Hersill Sl, cleared under FDA 510(k) K093241 on 27 Apr 2010 and listed in FDA GUDID since 17 Jan 2025 (UDI-DI 08435510678685), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08435510678685 | Date17 Jan 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK093241 | Date27 Apr 2010 | StatusActive |
Official records
- AccessGUDID record 08435510678685
- FDA 510(k) database K093241
Across registries
- FDA 510(k) K093241 decided 27 Apr 2010 Active
- FDA GUDID UDI-DI 08435510678685 listed 17 Jan 2025 Listed
Timeline
- Cleared FDA 510(k) K093241
- Listed FDA GUDID 08435510678685
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Care-E-Vac
- Generic name
- Emergency airway clearance suction system, electric
- Model / Ref / Catalog
- Care-e-vac EMS - Reusable jar, 5320216
- Primary DI / UDI-DI
- 08435510678685
- 510(k) Number
- FDA product code
- BTA
- GMDN term
- Emergency airway clearance suction system, electric
- Device class
- Class II
- Regulation number
- 878.4780
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code BTA (Pump, Portable, Aspiration (Manual Or Powered)).
- Docking Station 079.0037 by Medela AG
- Lid for safety Set with overflow protection device 077.0450 by Medela AG
- Lysonix Aspiration Pump by Lysonix, Inc.
- ELECTRIC VACUM PUMP by Impact Instrumentation, Inc.
- Electric Nasal Aspirator (BC026, BC025, BC023, BC028, BC029, BC036) by Shenzhen Kingboom Technology Co., Ltd.
- Medela Thopaz Model 200 0288 by Medela LLC
- S-Scort Duet Model 2014 Portable Suction Pump by SSCOR, INC.
- Care-E-Vac 3 by Ohio Medical LLC
- SmartSuction Solo Device by HAEMONETICS CORPORATION
- Model 8800 Aspirator by Medical Specifics, Inc.