K221836 is an FDA 510(k) clearance for the Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus. This device is classified as a Filter, Bacterial, Breathing-circuit (Class II - Special Controls, product code CAH).
Submitted by Dr?gerwerk AG & Co KGaA (Luebeck, DE). The FDA issued a Cleared decision on December 7, 2022, 167 days after receiving the submission on June 23, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.5260.
| 510(k) Number | K221836 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2022 |
| Decision Date | December 07, 2022 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | CAH - Filter, Bacterial, Breathing-circuit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5260 |