Cleared Traditional

K813159 - VACUSHIELD TM

K813159 is an FDA 510(k) clearance for VACUSHIELD TM, manufactured by Gelman Sciences, Inc.. The device is a Class 1 Chemistry device with product code JRL cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K813159 · Gelman Sciences, Inc. · Chemistry device
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Dec 1981
Decision
22d
Days
Class 1
Risk

K813159 is an FDA 510(k) clearance for the VACUSHIELD TM. Classified as Unit, Filter, Membrane (product code JRL), Class I - General Controls.

Submitted by Gelman Sciences, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 8, 1981 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2050 - 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 Gelman Sciences, Inc. devices

FDA 510(k) Submission Details - K813159

510(k) Number K813159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1981
Decision Date December 08, 1981
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

JRL Device Classification - Class 1, General Controls

Product Code JRL Unit, Filter, Membrane
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2050
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JRL Unit, Filter, Membrane

All 8
Devices cleared under the same product code (JRL) and FDA review panel - the closest regulatory comparables to K813159.
CENTRIFREE MICROPARTITION SYSTEM
K820455 · Amicon, Inc. · Mar 1982
EMIT FREELEVEL SYSTEM I
K820224 · Syva Co. · Feb 1982
IL 703, STAT SEPARATOR
K812750 · Instrumentation Laboratory CO · Jan 1982
ACRODISC
K810829 · Gelman Sciences, Inc. · Apr 1981
ULTRAFREE CALCIUM FILTER
K801500 · Millipore Corp. · Aug 1980
ULTRA-FREE
K790445 · Millipore Corp. · Jun 1979