Cleared Traditional

Pump Alignment Syringe

K220184 · Jiangsu Caina Medical Co.,Ltd · General Hospital
Jul 2022
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K220184 is an FDA 510(k) clearance for the Pump Alignment Syringe, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on July 21, 2022, 178 days after receiving the submission on January 24, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K220184 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2022
Decision Date July 21, 2022
Days to Decision 178 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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