Cleared Traditional

K853990 - OSM3 HEMOXIMETER (FDA 510(k) Clearance)

Class I Chemistry device.

K853990 · Radiometer America, Inc. · Chemistry device
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Dec 1985
Decision
94d
Days
Class 1
Risk

K853990 is an FDA 510(k) clearance for the OSM3 HEMOXIMETER. Classified as Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-monoxide (product code JKS), Class I - General Controls.

Submitted by Radiometer America, Inc. (Westlake, US). The FDA issued a Cleared decision on December 30, 1985 after a review of 94 days - within the typical 510(k) review window.

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

View all Radiometer America, Inc. devices

Submission Details

510(k) Number K853990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1985
Decision Date December 30, 1985
Days to Decision 94 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 88d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.