Cleared Traditional

K213881 - Celerity Incubator

K213881 is an FDA 510(k) clearance for Celerity Incubator, manufactured by STERIS Corporation. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K213881 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
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Jul 2022
Decision
220d
Days
Class 2
Risk

K213881 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 July 21, 2022 after a review of 220 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

FDA 510(k) Submission Details - K213881

510(k) Number K213881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2021
Decision Date July 21, 2022
Days to Decision 220 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
91d slower than avg
Panel avg: 129d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRC Device Classification - Class 2, Special Controls

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 180
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K213881.
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
3M Attest Rapid Readout Biological Indicator, 1295
K211705 · 3M Company · Jun 2022
Anprolene SteriTest RRBI
K213296 · Andersen Sterilizers, Inc. · Apr 2022
3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader
K213809 · 3M Company · Apr 2022