Cleared Traditional

K910320 - SERIM PERACETIC ACID REAGENT STRIPS

K910320 is the FDA 510(k) clearance for SERIM PERACETIC ACID REAGENT STRIPS by Serim Research Corp.. It is a Class 2 General Hospital device (product code JOJ) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K910320 · Serim Research Corp. · General Hospital
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May 1991
Decision
97d
Days
Class 2
Risk

K910320 is an FDA 510(k) clearance for the SERIM PERACETIC ACID REAGENT STRIPS. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on May 1, 1991 after a review of 97 days - within the typical 510(k) review window.

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 Serim Research Corp. devices

Submission Details

510(k) Number K910320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1991
Decision Date May 01, 1991
Days to Decision 97 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 129d · This submission: 97d
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 108
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K910320.
STERRAD CHEMICAL INDICATOR TAPE
K945190 · Advanced Sterilization Products · Dec 1994
3M AUTOCLAVE TAPES
K932129 · 3M Company · Mar 1994
STERRAD CHEMICAL INDICATOR
K921910 · Johnson & Johnson Medical, Inc. · Oct 1993
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