Cleared Traditional

K952336 - DISPATCH HOSPITAL CLEANER DISINFECTANT WITH BLEACH

K952336 is an FDA 510(k) clearance for DISPATCH HOSPITAL 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 102-day FDA review.

K952336 · Caltech Industries, Inc. · General Hospital
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Aug 1995
Decision
102d
Days
Class 1
Risk

K952336 is an FDA 510(k) clearance for the DISPATCH HOSPITAL CLEANER DISINFECTANT WITH BLEACH. 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 28, 1995 after a review of 102 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 - K952336

510(k) Number K952336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1995
Decision Date August 28, 1995
Days to Decision 102 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
27d faster than avg
Panel avg: 129d · This submission: 102d
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 K952336.
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K952336 · DISPATCH HOSPITAL CLEANER DISINFECTANT WITH BLEACH
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