Cleared Traditional

K241836 - Kem Medical Lead-free Chemical Indicato...

K241836 is an FDA 510(k) clearance for Kem Medical Lead-free Chemical Indicato..., manufactured by Kem Medical Products Corporation. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K241836 · Kem Medical Products Corporation · General Hospital
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Sep 2024
Decision
97d
Days
Class 2
Risk

K241836 is an FDA 510(k) clearance for the Kem Medical 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 Corporation (Hauppauge, US). The FDA issued a Cleared decision on September 30, 2024 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 Kem Medical Products Corporation devices

FDA 510(k) Submission Details - K241836

510(k) Number K241836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2024
Decision Date September 30, 2024
Days to Decision 97 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
32d faster than avg
Panel avg: 129d · This submission: 97d
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 153
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K241836.
Autoclave Indicator Tape
K241036 · Jiangmen New Era External Use Drug Co., Ltd. · Dec 2024
Chemical Indicator for enspire CLCSPS (LCC015)
K243475 · STERIS Corporation · Dec 2024
Getinge Assured MI Steam Migrating Integrator
K242795 · Steritec Products Mfg. (A Getinge Group Company) · Oct 2024
CELERITY HP Indicator Tape (PCC077)
K242189 · Steris · Aug 2024
STERRAD™ Chemical Indicator (CI) Strip (14100)
K234084 · Advanced Sterilization Products, Inc. · Jul 2024
Ultraphon Chemical Indicator (TRO-T and TRO-B)
K233413 · True Indicating, LLC · Jun 2024