510(k) K221836 · CAH Filter, Bacterial, Breathing-Circuit
Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
| Applicant | Drägerwerk AG & Co. KGaA, Luebeck, DE |
| Decision | Substantially Equivalent, Dec 7, 2022 |
| Received | Jun 23, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221836
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2025 | Draeger, Inc. SafeStar 90 Plus Filter. Bidirectionally breathing system filter. Open, Classified |
CAH | None listed |
| Jul 31, 2025 | Draeger, Inc. SafeStar 55 Plus Filter. Bidirectionally breathing system filter. Open, Classified |
CAH | None listed |
| Jul 31, 2025 | Draeger, Inc. HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter. Open, Classified |
CAH | None listed |
| Jul 31, 2025 | Draeger, Inc. SafeStar 60A Plus Filter. Bidirectionally breathing system filter. Open, Classified |
CAH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.