Cleared Traditional

K862253 - IL 482 CO-OXIMETER

K862253 is an FDA 510(k) clearance for IL 482 CO-OXIMETER, manufactured by Instrumentation Laboratory CO. The device is a Class 1 Chemistry device with product code JKS cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K862253 · Instrumentation Laboratory CO · Chemistry device
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Jul 1986
Decision
46d
Days
Class 1
Risk

K862253 is an FDA 510(k) clearance for the IL 482 CO-OXIMETER. Classified as Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-monoxide (product code JKS), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on July 29, 1986 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3220 - 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.

FDA 510(k) Submission Details - K862253

510(k) Number K862253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1986
Decision Date July 29, 1986
Days to Decision 46 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
42d faster than avg
Panel avg: 88d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

JKS Device Classification - Class 1, General Controls

Product Code JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-monoxide
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3220
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 - JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-monoxide

Devices cleared under the same product code (JKS) and FDA review panel - the closest regulatory comparables to K862253.
AVOXIMETER 4000
K951485 · A-Vox Systems, Inc. · Nov 1995
CO-OXIMETER SOLUTIONS
K863825 · D.R.G. Scientific Industries · Nov 1986
OSM3 HEMOXIMETER
K853990 · Radiometer America, Inc. · Dec 1985
TEE ADAPTER 9890-FLUSH WINDING 282
K833693 · Shaban Mfg. Co. · Dec 1983
BILE SALTS MIXTURE
K833211 · Acumedia Manufacturers, Inc. · Oct 1983
K862253 · IL 482 CO-OXIMETER
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