Cleared Traditional

K822784 - HEMO-DE (FDA 510(k) Clearance)

Class I Pathology device.

K822784 · Pmp Industries · Pathology device
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Nov 1982
Decision
52d
Days
Class 1
Risk

K822784 is an FDA 510(k) clearance for the HEMO-DE. Classified as Agent, Clearing (product code KEM), Class I - General Controls.

Submitted by Pmp Industries (Anaheim, US). The FDA issued a Cleared decision on November 5, 1982 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.4010 - the FDA pathology 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: 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 K822784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1982
Decision Date November 05, 1982
Days to Decision 52 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 77d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KEM Agent, Clearing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.4010
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.