Cleared Traditional

K181788 - Lead-free Chemical Indicators for Steam Sterilization

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

K181788 · Kem Medical Products Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K181788

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.

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 217
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