Cleared Traditional

ORS-300 (K921570) - FDA 510(k) Clearance

Class I Chemistry device.

K921570 · Mnlase, Inc. · Chemistry device
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Jun 1992
Decision
68d
Days
Class 1
Risk

K921570 is an FDA 510(k) clearance for the ORS-300. Classified as Freezer (product code JRM), Class I - General Controls.

Submitted by Mnlase, Inc. (Reston, US). The FDA issued a Cleared decision on June 9, 1992 after a review of 68 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 Mnlase, Inc. devices

Submission Details

510(k) Number K921570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1992
Decision Date June 09, 1992
Days to Decision 68 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 88d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JRM Freezer
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.