Cleared Traditional

K861490 - PERMACLEAR SOLUTION CAT. NO. 4950

K861490 is an FDA 510(k) clearance for PERMACLEAR SOLUTION CAT. NO. 4950, manufactured by Helena Laboratories. The device is a Class 1 Pathology device with product code KEM cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K861490 · Helena Laboratories · Pathology device
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May 1986
Decision
14d
Days
Class 1
Risk

K861490 is an FDA 510(k) clearance for the PERMACLEAR SOLUTION CAT. NO. 4950. Classified as Agent, Clearing (product code KEM), Class I - General Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on May 6, 1986 after a review of 14 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.

View all Helena Laboratories devices

FDA 510(k) Submission Details - K861490

510(k) Number K861490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1986
Decision Date May 06, 1986
Days to Decision 14 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 77d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

KEM Device Classification - Class 1, General Controls

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.

Regulatory Peers - KEM Agent, Clearing

All 7
Devices cleared under the same product code (KEM) and FDA review panel - the closest regulatory comparables to K861490.
CLEARENE, CLEARING AGENT
K855109 · Surgipath Medical Industries, Inc. · Jan 1986
LIMONENE
K842721 · E K Ind., Inc. · Aug 1984
CLEAR-RITE 3
K832451 · Richard-Allan Medical Ind., Inc. · Aug 1983
CLARIFIER-RICHARD-ALLAN
K830627 · Richard-Allan Medical Ind., Inc. · Mar 1983
CLEAR-RITE II
K812846 · Richard-Allan Medical Ind., Inc. · Oct 1981
XYLENE
K812847 · Richard-Allan Medical Ind., Inc. · Oct 1981