Cleared Special

K192020 - Celerity HP Chemical Indicator

K192020 is the FDA 510(k) clearance for Celerity HP Chemical Indicator by STERIS Corporation. It is a Class 2 General Hospital device (product code JOJ) cleared through the Special 510(k) pathway after a 38-day FDA review.

K192020 · STERIS Corporation · General Hospital
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Sep 2019
Decision
38d
Days
Class 2
Risk

K192020 is an FDA 510(k) clearance for the Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Ad.... Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on September 5, 2019 after a review of 38 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 Corporation devices

Submission Details

510(k) Number K192020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2019
Decision Date September 05, 2019
Days to Decision 38 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
91d faster than avg
Panel avg: 129d · This submission: 38d
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 K192020.
3M Comply Hydrogen Peroxide Chemical Indicator
K192937 · 3M Company · Nov 2019
3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228
K192673 · 3M Company · Oct 2019
Sterilucent VH2O2 Chemical Indicators
K191999 · Sterilucent, Inc. · Oct 2019
Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape
K191741 · Intertape Polymer, Inc. · Aug 2019
Lead-free Chemical Indicators for Steam Sterilization
K181788 · Kem Medical Products Corp. · Mar 2019
3M Comply Hydrogen Peroxide Chemical Indicator
K183211 · 3M Company · Feb 2019