Cleared Traditional

K213262 - CELERITY HP Chemical Indicator (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213262 · STERIS Corporation · General Hospital
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Jan 2022
Decision
99d
Days
Class 2
Risk

K213262 is an FDA 510(k) clearance for the CELERITY HP Chemical Indicator. Classified as A Chemical Vapor Sterilization Multivariable Chemical Indicator (product code QKM), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on January 7, 2022 after a review of 99 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.

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Submission Details

510(k) Number K213262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2021
Decision Date January 07, 2022
Days to Decision 99 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
29d faster than avg
Panel avg: 128d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QKM A Chemical Vapor Sterilization Multivariable Chemical Indicator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
Definition A Chemical Vapor Sterilization Multivariable Chemical Indicator Monitors Two Or More Parameters Of A Chemical Vapor Sterilization Process.
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 - QKM A Chemical Vapor Sterilization Multivariable Chemical Indicator

Devices cleared under the same product code (QKM) and FDA review panel - the closest regulatory comparables to K213262.
Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
K232103 · Terragene S.A. · Apr 2024
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
K212022 · 3M Company · Apr 2022
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator
K203284 · 3M Company · Dec 2020