Cleared Traditional

K952302 - AMUCHINA

K952302 is an FDA 510(k) clearance for AMUCHINA, manufactured by Amuchina Intl., Inc.. The device is a Class 1 General Hospital device with product code LRJ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K952302 · Amuchina Intl., Inc. · General Hospital
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Jul 1995
Decision
71d
Days
Class 1
Risk

K952302 is an FDA 510(k) clearance for the AMUCHINA. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by Amuchina Intl., Inc. (Gaithersburg, US). The FDA issued a Cleared decision on July 26, 1995 after a review of 71 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6890 - the FDA general hospital 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 Amuchina Intl., Inc. devices

FDA 510(k) Submission Details - K952302

510(k) Number K952302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1995
Decision Date July 26, 1995
Days to Decision 71 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 129d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

LRJ Device Classification - Class 1, General Controls

Product Code LRJ Disinfectant, Medical Devices
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6890
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 - LRJ Disinfectant, Medical Devices

All 38
Devices cleared under the same product code (LRJ) and FDA review panel - the closest regulatory comparables to K952302.
PRO-TECH
K955850 · Central Solutions, Inc. · Feb 1996
KLORMAN
K923693 · Matrix Medica, Inc. · Jan 1996
VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT
K934014 · Biotrol, USA, Inc. · Dec 1995
RENALIN COLD STERILANT
K941439 · Minntech Corp. · Jun 1995
AMERSE
K931477 · Calgon Vestal Div. · Jun 1994
LPH
K931342 · Calgon Vestal Div. · May 1994