Cleared Traditional

K855109 - CLEARENE, CLEARING AGENT

K855109 is an FDA 510(k) clearance for CLEARENE, manufactured by Surgipath Medical Industries, Inc.. The device is a Class 1 Pathology device with product code KEM cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K855109 · Surgipath Medical Industries, Inc. · Pathology device
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Jan 1986
Decision
15d
Days
Class 1
Risk

K855109 is an FDA 510(k) clearance for the CLEARENE, CLEARING AGENT. Classified as Agent, Clearing (product code KEM), Class I - General Controls.

Submitted by Surgipath Medical Industries, Inc. (Grayslake, US). The FDA issued a Cleared decision on January 7, 1986 after a review of 15 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.

FDA 510(k) Submission Details - K855109

510(k) Number K855109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1985
Decision Date January 07, 1986
Days to Decision 15 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: 78d · This submission: 15d
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 14
Devices cleared under the same product code (KEM) and FDA review panel - the closest regulatory comparables to K855109.
XYLENE
K881282 · Anatech, Ltd. · Apr 1988
HEMO-SOL
K874461 · Chem Pharm, Inc. · Dec 1987
PERMACLEAR SOLUTION CAT. NO. 4950
K861490 · Helena Laboratories · May 1986
XYLENE SUBSTITUTE
K853694 · Lerner Laboratories, Inc. · Oct 1985
XYLENE SUBSTITUTE MONTANT
K854083 · Lerner Laboratories, Inc. · Oct 1985
PRO-PAR CLEARANT
K842861 · Anatech, Ltd. · Aug 1984
K855109 · CLEARENE, CLEARING AGENT
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