Cleared Traditional

K202721 - Celerity 20 Steam Biological Indicator ...

K202721 is the FDA 510(k) clearance for Celerity 20 Steam Biological Indicator ... by STERIS Corporation. It is a Class 2 General Hospital device (product code FRC) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K202721 · STERIS Corporation · General Hospital
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Jan 2021
Decision
113d
Days
Class 2
Risk

K202721 is an FDA 510(k) clearance for the Celerity 20 Steam Biological Indicator for IUSS. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on January 8, 2021 after a review of 113 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 STERIS Corporation devices

Submission Details

510(k) Number K202721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2020
Decision Date January 08, 2021
Days to Decision 113 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
16d faster than avg
Panel avg: 129d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRC Indicator, Biological 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 - FRC Indicator, Biological Sterilization Process

All 114
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