Cleared Traditional

K952516 - PRO-VENT

K952516 is an FDA 510(k) clearance for PRO-VENT, manufactured by Smiths Industries Medical Systems, Inc.. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K952516 · Smiths Industries Medical Systems, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Jul 1995
Decision
44d
Days
Class 2
Risk

K952516 is an FDA 510(k) clearance for the PRO-VENT, LINE DRAW, PULSATOR. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Smiths Industries Medical Systems, Inc. (Keene, US). The FDA issued a Cleared decision on July 14, 1995 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smiths Industries Medical Systems, Inc. devices

FDA 510(k) Submission Details - K952516

510(k) Number K952516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1995
Decision Date July 14, 1995
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 88d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKA Device Classification - Class 2, Special Controls

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 128
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K952516.
VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET
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PICO MODELS 30, 50, 70
K962158 · Radiometer America, Inc. · Oct 1996
SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT
K962931 · Smiths Industries Medical Systems, Inc. · Oct 1996
MONOJECT(R) SAMPLETTE(R) COLLECTION TUBE
K944083 · Sherwood Medical Co. · May 1995
VACUTAINER BRAND SAFETY-LOK NEEDLE HOLDER
K950432 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1995
VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE
K945952 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1995