Cleared Traditional

K770398 - MINICON (FDA 510(k) Clearance)

Class I Immunology device.

K770398 · Amicon, Inc. · Immunology device
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Apr 1977
Decision
35d
Days
Class 1
Risk

K770398 is an FDA 510(k) clearance for the MINICON. Classified as Clinical Sample Concentrator (product code JJH), Class I - General Controls.

Submitted by Amicon, Inc. (Walker, US). The FDA issued a Cleared decision on April 6, 1977 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.2310 - the FDA immunology 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.

View all Amicon, Inc. devices

Submission Details

510(k) Number K770398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1977
Decision Date April 06, 1977
Days to Decision 35 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 104d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJH Clinical Sample Concentrator
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2310
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.