Cleared Traditional

K192445 - QwikCheck Chemical Indicators

K192445 is the FDA 510(k) clearance for QwikCheck Chemical Indicators by Serim Research Corporation. It is a Class 2 General Hospital device (product code JOJ) cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K192445 · Serim Research Corporation · General Hospital
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Apr 2020
Decision
209d
Days
Class 2
Risk

K192445 is an FDA 510(k) clearance for the QwikCheck Chemical Indicators. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Serim Research Corporation (Elkhart, US). The FDA issued a Cleared decision on April 2, 2020 after a review of 209 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 Serim Research Corporation devices

Submission Details

510(k) Number K192445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2019
Decision Date April 02, 2020
Days to Decision 209 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
80d slower than avg
Panel avg: 129d · This submission: 209d
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 114
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K192445.
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K200252 · Steritec Products Mfg Co, Inc. · May 2020
3M Attest Steam Chemical Integrator
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3M™ Attest™ Steam Chemical Integrators
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3M Comply Hydrogen Peroxide Chemical Indicator
K192937 · 3M Company · Nov 2019