Cleared Traditional

K931935 - ENDPOINT 500 PERACETIC ACID TEST INDICA...

K931935 is the FDA 510(k) clearance for ENDPOINT 500 PERACETIC ACID TEST INDICA... by Minntech Corp.. It is a Class 2 General Hospital device (product code JOJ) cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K931935 · Minntech Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
294d
Days
Class 2
Risk

K931935 is an FDA 510(k) clearance for the ENDPOINT 500 PERACETIC ACID TEST INDICATORS. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Minntech Corp. (Minneapolis, US). The FDA issued a Cleared decision on February 7, 1994 after a review of 294 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - 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.

View all Minntech Corp. devices

Submission Details

510(k) Number K931935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1993
Decision Date February 07, 1994
Days to Decision 294 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 129d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOJ Indicator, Physical/chemical Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - JOJ Indicator, Physical/chemical Sterilization Process

All 100
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K931935.
3M COMPLY 1228 GAS PLASMA INDICATOR TAPE
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KIMBERLY-CLARK GAS PLASMA STERILIZATION INDICATOR STRIP
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3M AUTOCLAVE TAPES
K932129 · 3M Company · Mar 1994
BOWIE-DICK TEST CARD CATALOG NUMBER 008018
K897045 · Edward Weck, Inc. · Feb 1990
TOWER SELF SEAL STERILIZATION POUCH
K895422 · Baxter Healthcare Corp · Nov 1989
CHEMICAL AUTOCLAVE INDICATOR TAPE
K811936 · American Hospital Supply Corp. · Jul 1981