Cleared Special

K242189 - CELERITY HP Indicator Tape (PCC077)

K242189 is the FDA 510(k) clearance for CELERITY HP Indicator Tape (PCC077) by Steris. It is a Class 2 General Hospital device (product code JOJ) cleared through the Special 510(k) pathway after a 26-day FDA review.

K242189 · Steris · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
26d
Days
Class 2
Risk

K242189 is an FDA 510(k) clearance for the CELERITY HP Indicator Tape (PCC077). Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Steris (Mentor, US). The FDA issued a Cleared decision on August 20, 2024 after a review of 26 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Steris devices

Submission Details

510(k) Number K242189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2024
Decision Date August 20, 2024
Days to Decision 26 days
Submission Type Special
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
103d faster than avg
Panel avg: 129d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 K242189.
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
Kem Medical Lead-free Chemical Indicators for Steam Sterilization
K241836 · Kem Medical Products Corporation · Sep 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
EO Chex Indicator Tape
K240910 · Propper Manufacturing Co., Inc. · Jun 2024