Cleared Traditional

OSMOMETER MODEL OM-6010 (K811179) - FDA 510(k) Clearance

Class I Chemistry device.

K811179 · Fiske Med Science · Chemistry device
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May 1981
Decision
17d
Days
Class 1
Risk

K811179 is an FDA 510(k) clearance for the OSMOMETER MODEL OM-6010. Classified as Osmometer For Clinical Use (product code JJM), Class I - General Controls.

Submitted by Fiske Med Science (Mchenry, US). The FDA issued a Cleared decision on May 15, 1981 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2730 - 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.

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Submission Details

510(k) Number K811179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1981
Decision Date May 15, 1981
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 88d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJM Osmometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2730
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.