510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221836Substantially Equivalent

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus

Drägerwerk AG & Co. KGaA, Luebeck, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221836 is the FDA 510(k) clearance record for Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus, a class II device, cleared for Drägerwerk AG & Co. KGaA on under FDA product code CAH (Filter, Bacterial, Breathing-Circuit). FDA records list 5 510(k) clearances for Drägerwerk AG & Co. KGaA, from to . As of , FDA records show 4 recalls naming K221836.

Clearance record

Decision date
Received
(167 days to decision)
Product code
CAH Filter, Bacterial, Breathing-Circuit
Regulation
21 CFR 868.5260
Device class
Class II
Review panel
Anesthesiology
Applicant
Drägerwerk AG & Co. KGaA Moislinger Allee 53-55, Luebeck, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CAH

Trailing 12 months
2 clearances under product code CAH in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CAH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260