Cleared Traditional

K812750 - IL 703, STAT SEPARATOR

K812750 is an FDA 510(k) clearance for IL 703, manufactured by Instrumentation Laboratory CO. The device is a Class 1 Hematology device with product code JRL cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K812750 · Instrumentation Laboratory CO · Hematology device
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Jan 1982
Decision
119d
Days
Class 1
Risk

K812750 is an FDA 510(k) clearance for the IL 703, STAT SEPARATOR. Classified as Unit, Filter, Membrane (product code JRL), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on January 26, 1982 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.2050 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K812750

510(k) Number K812750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1981
Decision Date January 26, 1982
Days to Decision 119 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 113d · This submission: 119d
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 K812750.
ACRO PACK
K822121 · Gelman Sciences, Inc. · Aug 1982
CENTRIFREE MICROPARTITION SYSTEM
K820455 · Amicon, Inc. · Mar 1982
EMIT FREELEVEL SYSTEM I
K820224 · Syva Co. · Feb 1982
VACUSHIELD TM
K813159 · Gelman Sciences, Inc. · Dec 1981
ACRODISC
K810829 · Gelman Sciences, Inc. · Apr 1981
ULTRAFREE CALCIUM FILTER
K801500 · Millipore Corp. · Aug 1980