Cleared Traditional

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

K221836 · Dr?gerwerk AG & Co KGaA · General Hospital
Dec 2022
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K221836 is an FDA 510(k) clearance for the Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus, 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 review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number K221836 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code CAH — Filter, Bacterial, Breathing-circuit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5260

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