REMSTAR AUTO A-FLEX HT
FDA 510(k) clearance K131982 · decided 2013-10-18
Clearance details
- K-number
- K131982
- Device name
- REMSTAR AUTO A-FLEX HT
- Applicant
- Respironics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-06-28
- Decision date
- 2013-10-18
- Days to decision
- 112 days
- Clearance type
- Special
- Product code
- BZD
- Device class
- 2
- Regulation number
- 868.5905
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Murrysville, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DreamStation Auto CPAP. Non-Continuous Ventilator. recall (Z-2227-2025) | Philips Respironics, Inc. | 2025-08-08 |
| DreamStation Auto BiPAP. Non-Continuous Ventilator. recall (Z-2228-2025) | Philips Respironics, Inc. | 2025-08-08 |
| DreamStation Auto. Non-Continuous Ventilator. recall (Z-2229-2025) | Philips Respironics, Inc. | 2025-08-08 |
| Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S1 recall (Z-1322-2023) | Philips Respironics, Inc. | 2023-04-06 |
| SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto recall (Z-1974-2021) | Philips Respironics, Inc. | 2021-07-13 |