Cleared Traditional

CELERITY 20 HP Biological Indicator (K172752) - FDA 510(k) Clearance

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

K172752 · STERIS Corporation · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2018
Decision
150d
Days
Class 2
Risk

K172752 is an FDA 510(k) clearance for the CELERITY 20 HP Biological Indicator. 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 February 9, 2018 after a review of 150 days - an extended review cycle.

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 K172752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2017
Decision Date February 09, 2018
Days to Decision 150 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
21d slower than avg
Panel avg: 129d · This submission: 150d
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 88
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K172752.
CELERITY 20 Steam Biological Indicator
K173634 · STERIS Corporation · Feb 2018
CELERITY 20 Steam Incubator
K173670 · STERIS Corporation · Feb 2018
VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack
K172748 · Steris Corporations · Feb 2018
3M Attest Rapid Readout Biological Indicator
K173435 · 3M Company · Feb 2018
Sporview VH202 BI
K171287 · Spsmedical Supply Corp. A Division of Cantel Medical · Feb 2018
3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader
K173584 · 3M Company · Jan 2018