Cleared Traditional

K931935 - ENDPOINT 500 PERACETIC ACID TEST INDICATORS

K931935 is an FDA 510(k) clearance for ENDPOINT 500 PERACETIC ACID TEST INDICATORS, manufactured by Minntech Corp.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K931935

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
Combination Product No
PCCP Authorized No
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.

JOJ Device Classification - Class 2, Special Controls

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 204
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K931935.
STERIGAGE EO 100%
K934874 · Pymah Corp. · Apr 1995
STERRAD CHEMICAL INDICATOR TAPE
K945190 · Advanced Sterilization Products · Dec 1994
3M AUTOCLAVE TAPES
K932129 · 3M Company · Mar 1994
GLUTARALDEHYDE MONITORS
K924681 · Pymah Corp. · Nov 1993
STERRAD CHEMICAL INDICATOR
K921910 · Johnson & Johnson Medical, Inc. · Oct 1993
CHEMDI-VHP CHEMICAL INDICATOR
K922485 · American Sterilizer Co. · Sep 1993