Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus— 510(k) K221836
Substantially EquivalentDrägerwerk AG & Co. KGaA
FDA 510(k) clearance K221836 for Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus, Substantially Equivalent on 2022-12-07. Applicant: Drägerwerk AG & Co. KGaA. Device class: 2.
Clearance details
- Applicant
- Drägerwerk AG & Co. KGaA
- Product code
- Code CAH
- Device class
- Class 2
- Regulation
- 21 CFR 868.5260
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Luebeck, DE
Recent devices under product code CAH
view allMore clearances from Drägerwerk AG & Co. KGaA
view allAdverse events under product code CAH
product code CAH- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K221836
K-number listed on FDA's recall record- Z-2158-2025 — SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
- Z-2159-2025 — SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
- Z-2160-2025 — HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
- Z-2161-2025 — SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K221836.
Data sourced from openFDA. This site is unofficial and independent of the FDA.