Cleared Traditional

K830627 - CLARIFIER-RICHARD-ALLAN

K830627 is an FDA 510(k) clearance for CLARIFIER-RICHARD-ALLAN, manufactured by Richard-Allan Medical Ind., Inc.. The device is a Class 1 Pathology device with product code KEM cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K830627 · Richard-Allan Medical Ind., Inc. · Pathology device
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Mar 1983
Decision
23d
Days
Class 1
Risk

K830627 is an FDA 510(k) clearance for the CLARIFIER-RICHARD-ALLAN. Classified as Agent, Clearing (product code KEM), Class I - General Controls.

Submitted by Richard-Allan Medical Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 23 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 Richard-Allan Medical Ind., Inc. devices

FDA 510(k) Submission Details - K830627

510(k) Number K830627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1983
Decision Date March 24, 1983
Days to Decision 23 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
54d faster than avg
Panel avg: 77d · This submission: 23d
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 K830627.
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
CLEAR-RITE II
K812846 · Richard-Allan Medical Ind., Inc. · Oct 1981
XYLENE
K812847 · Richard-Allan Medical Ind., Inc. · Oct 1981
CLEAR-RITE
K811798 · Richard-Allan Medical Ind., Inc. · Jul 1981