Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
FDA 510(k) clearance K221836 · decided 2022-12-07
Clearance details
- K-number
- K221836
- Device name
- Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
- Applicant
- Drägerwerk AG & Co. KGaA
- Decision
- Substantially Equivalent
- Date received
- 2022-06-23
- Decision date
- 2022-12-07
- Days to decision
- 167 days
- Clearance type
- Traditional
- Product code
- CAH
- Device class
- 2
- Regulation number
- 868.5260
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Luebeck, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SafeStar 90 Plus Filter. Bidirectionally breathing system filter. recall (Z-2158-2025) | Draeger, Inc. | 2025-07-31 |
| SafeStar 55 Plus Filter. Bidirectionally breathing system filter. recall (Z-2159-2025) | Draeger, Inc. | 2025-07-31 |
| HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter. recall (Z-2160-2025) | Draeger, Inc. | 2025-07-31 |
| SafeStar 60A Plus Filter. Bidirectionally breathing system filter. recall (Z-2161-2025) | Draeger, Inc. | 2025-07-31 |