Cleared Traditional

K181788 - Lead-free Chemical Indicators for Steam...

K181788 is the FDA 510(k) clearance for Lead-free Chemical Indicators for Steam... by Kem Medical Products Corp.. It is a Class 2 General Hospital device (product code JOJ) cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K181788 · Kem Medical Products Corp. · General Hospital
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Mar 2019
Decision
239d
Days
Class 2
Risk

K181788 is an FDA 510(k) clearance for the Lead-free Chemical Indicators for Steam Sterilization. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Kem Medical Products Corp. (Farmingdale, US). The FDA issued a Cleared decision on March 1, 2019 after a review of 239 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 Kem Medical Products Corp. devices

Submission Details

510(k) Number K181788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2018
Decision Date March 01, 2019
Days to Decision 239 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
110d slower than avg
Panel avg: 129d · This submission: 239d
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 K181788.
Sterilucent VH2O2 Chemical Indicators
K191999 · Sterilucent, Inc. · Oct 2019
Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label
K192020 · STERIS Corporation · Sep 2019
Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape
K191741 · Intertape Polymer, Inc. · Aug 2019
3M Comply Hydrogen Peroxide Chemical Indicator
K183211 · 3M Company · Feb 2019
3M Comply Hydrogen Peroxide Indicator Tape
K183209 · 3M Company · Feb 2019
VERIFY VH202 Indicator Tape
K183293 · STERIS Corporation · Jan 2019