Cleared Traditional

K951512 - PRECISE HOSPITAL FOAM CLEANER DISINFECTANT

K951512 is an FDA 510(k) clearance for PRECISE HOSPITAL FOAM CLEANER DISINFECTANT, manufactured by Caltech Industries, Inc.. The device is a Class 1 General Hospital device with product code LRJ cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K951512 · Caltech Industries, Inc. · General Hospital
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Aug 1995
Decision
126d
Days
Class 1
Risk

K951512 is an FDA 510(k) clearance for the PRECISE HOSPITAL FOAM CLEANER DISINFECTANT. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by Caltech Industries, Inc. (Midland, US). The FDA issued a Cleared decision on August 7, 1995 after a review of 126 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K951512

510(k) Number K951512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1995
Decision Date August 07, 1995
Days to Decision 126 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 129d · This submission: 126d
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 72
Devices cleared under the same product code (LRJ) and FDA review panel - the closest regulatory comparables to K951512.
FORMULATION HWS-128 EPA REG. NO. 47371-130
K953009 · Huntington Laboratories, Inc. · Aug 1995
FORMULATION HWS-256 EPA REG. NO. 47371-129
K953010 · Huntington Laboratories, Inc. · Aug 1995
FORMULATION HWS-64 EPA REG. NO. 47371-131
K953011 · Huntington Laboratories, Inc. · Aug 1995
AMUCHINA
K952302 · Amuchina Intl., Inc. · Jul 1995
PHENO-CEN GERMICIDAL DETERGENT
K951162 · Central Solutions, Inc. · Jul 1995
RENALIN COLD STERILANT
K941439 · Minntech Corp. · Jun 1995
K951512 · PRECISE HOSPITAL FOAM CLEANER DISINFECTANT
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