Critical Care Ventilator
by Oricare Inc.
510(k) K120931
Critical Care Ventilator is a Class II device made by Oricare Inc., cleared under FDA 510(k) K120931 on 6 Jun 2013, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK120931 | Date6 Jun 2013 | StatusActive |
Official records
- FDA 510(k) database K120931
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CBK
- FDA applicant
- Oricare, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5895
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K120931
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| V8800 Critical Care Ventilator | 0081508502023 / V8800 | 00815085020238 | — | On the market |
| V8800 Critical Care Ventilator | 0081508502024 / V8800 | 00815085020245 | — | On the market |
| V8800 Critical Care Ventilator | 0081508502025 / V8800 | 00815085020252 | — | On the market |
| V8800 Critical Care Ventilator | 0081508502026 / V8800 | 00815085020269 | — | On the market |
| V8800 Critical Care Ventilator | 0081508502027 / V8800 | 00815085020276 | — | On the market |
| V8800 Critical Care Ventilator | 0081508502028 / V8800 | 00815085020283 | — | On the market |
| V8800 Critical Care Ventilator | 0081508502029 / V8800 | 00815085020290 | — | On the market |
| V8800 Critical Care Ventilator | 0081508502030 / V8800 | 00815085020306 | — | On the market |
| V8800 Critical Care Ventilator | 0081508502031 / V8800 | 00815085020313 | — | On the market |
| V8800 Critical Care Ventilator | 0081508502032 / V8800 | 00815085020320 | — | On the market |
| V8800 Critical Care Ventilator | 0081508502033 / V8800 | 00815085020337 | — | On the market |
| V8800 Critical Care Ventilator | 0081508502035 / V8800 | 00815085020351 | — | On the market |
| V8800 Critical Care Ventilator | 0081508502036 / V8800 | 00815085020368 | — | On the market |
| V8800 Critical Care Ventilator | 0081508502037 / V8800 | 00815085020375 | — | On the market |
| V8800 Critical Care Ventilator | 0081508502038 / V8800 | 00815085020382 | — | On the market |
| V8800 Critical Care Ventilator | 0081508502039 / V8800 | 00815085020399 | — | On the market |
| V8800 Critical Care Ventilator | V8800 | 00815085020436 | — | On the market |
| V8800 Critical Care Ventilator | V8800 | 00815085020405 | — | On the market |
| V8800 Critical Care Ventilator | V8800 | 00815085020443 | — | On the market |
| V8800 Critical Care Ventilator | V8800 | 00815085020344 | — | On the market |
| V8800 Critical Care Ventilator | V8800 | 00815085020429 | — | On the market |
| V8800 Critical Care Ventilator | V8800 | 00815085020412 | — | On the market |
Similar devices
Other devices filed under FDA product code CBK (Ventilator, Continuous, Facility Use).
- PERFORMAX 1083086 by Respironics Inc.
- Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082) by Draeger Medical B.V.
- Servo Ventilator System, Model 64 87 800 E407E by SIEMENS MEDICAL SOLUTIONS USA, INC.
- Sechrist IV-100B SAVI System by Sechrist
- Venturi Ventilator Modification by Cardiopulmonary Corp.
- Ohmeda 7400 Anesthesia Ventilator by Ohmeda Medical
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- Babylog VN800 8422400 by Drägerwerk AG & Co. KGaA
- Ventoux VC3 VX-12-0-0N1 by FLIGHT MEDICAL INNOVATIONS LTD
- Evitaxl With Option SmartCare by Drager Medical AG & Co. Kgaa