Cleared Traditional

SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT

K962931 · Smiths Industries Medical Systems, Inc. · Chemistry
Oct 1996
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K962931 is an FDA 510(k) clearance for the SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Smiths Industries Medical Systems, Inc. (Keene, US). The FDA issued a Cleared decision on October 21, 1996, 84 days after receiving the submission on July 29, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K962931 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1996
Decision Date October 21, 1996
Days to Decision 84 days
Submission Type Traditional
Review Panel Chemistry (CH)
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