Cleared Traditional

K223715 - Celerity Incubator

K223715 is the FDA 510(k) clearance for Celerity Incubator by STERIS Corporation. It is a Class 2 General Hospital device (product code FRC) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K223715 · STERIS Corporation · General Hospital
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Jun 2023
Decision
195d
Days
Class 2
Risk

K223715 is an FDA 510(k) clearance for the Celerity Incubator. 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 June 15, 2023 after a review of 195 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 K223715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2022
Decision Date June 15, 2023
Days to Decision 195 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
66d slower than avg
Panel avg: 129d · This submission: 195d
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
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K223715.
3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD)
K233814 · 3M Company · Mar 2024
ConFirm 20 Minute Incubator
K233681 · STERIS Corporation · Dec 2023
Celerity 20 HP Biological Indicator
K231490 · STERIS Corporation · Aug 2023
Celerity 5 HP Biological Indicator
K223717 · STERIS Corporation · Jun 2023
Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
K223023 · Plasmapp Co,., Ltd. · May 2023
Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)
K221641 · Terragene S.A. · Feb 2023