Cleared Traditional

K202721 - Celerity 20 Steam Biological Indicator for IUSS (FDA 510(k) Clearance)

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

K202721 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
15d faster than avg
Panel avg: 128d · 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 205
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K202721.
Celerity 5 HP Biological Indicator (LCB052)
K260766 · STERIS Corporation · Apr 2026
Celerity™ 20 HP Biological Indicator
K252680 · STERIS Corporation · Sep 2025
Terragene® Bionova® BT20 Biological Indicator
K251122 · Terragene · Aug 2025
Celerity 5 HP Biological Indicator (LCB052)
K251452 · Steris · Jun 2025
Celerity 5 HP Biological Indicator (LCB052)
K250044 · STERIS Corporation · Feb 2025
Celerity Incubator
K250061 · STERIS Corporation · Feb 2025