Cleared Traditional

Safety Push Button Blood Collection Set

K222834 · Jiangsu Caina Medical Co.,Ltd · General Hospital
Jan 2023
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K222834 is an FDA 510(k) clearance for the Safety Push Button Blood Collection Set, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on January 5, 2023, 107 days after receiving the submission on September 20, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K222834 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2022
Decision Date January 05, 2023
Days to Decision 107 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1675

Similar Devices — JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 232
BD Vacutainer? Plasma Separator Tubes (PST?), BD Vacutainer? Sodium Heparin Blood Collection Tubes
K252040 · Becton, Dickinson and Company · Mar 2026
Steripath? Flow? Blood Collection System
K251812 · Magnolia Medical Technologies · Sep 2025
BD Vacutainer? Eclipse? Blood Collection Needle
K243207 · Becton, Dickinson and Company · Jul 2025
Blood collection tube holders
K250961 · Promisemed Hangzhou Meditech Co., Ltd. · Jun 2025
Navi? Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)
K244047 · Venocare, Inc. · May 2025
Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set
K250907 · Sol-Millennium Medical, Inc. · Apr 2025