VOCSN Unified Respiratory System
FDA 510(k) clearance K162877 · decided 2017-04-07
Clearance details
- K-number
- K162877
- Device name
- VOCSN Unified Respiratory System
- Applicant
- Ventec Life Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-10-14
- Decision date
- 2017-04-07
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bothell, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001 recall (Z-2525-2026) | Ventec Life Systems, Inc. | 2026-06-23 |
| VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000 recall (Z-1942-2026) | Ventec Life Systems, Inc. | 2026-05-01 |
| VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; recall (Z-1196-2025) | Ventec Life Systems, Inc. | 2025-02-26 |
| VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with p recall (Z-1070-2024) | Ventec Life Systems, Inc. | 2024-02-23 |
| Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+ recall (Z-1902-2021) | Ventec Life Systems, Inc. | 2021-06-21 |