Cleared Traditional

Needleless Connector

K210217 · Jiangsu Caina Medical Co.,Ltd · General Hospital
May 2021
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K210217 is an FDA 510(k) clearance for the Needleless Connector, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on May 17, 2021, 110 days after receiving the submission on January 27, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K210217 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2021
Decision Date May 17, 2021
Days to Decision 110 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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