Cleared Traditional

K190297 - Celerity HP Incubator

K190297 is an FDA 510(k) clearance for Celerity HP 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 92-day FDA review.

K190297 · STERIS Corporation · General Hospital
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May 2019
Decision
92d
Days
Class 2
Risk

K190297 is an FDA 510(k) clearance for the Celerity HP 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 May 14, 2019 after a review of 92 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

FDA 510(k) Submission Details - K190297

510(k) Number K190297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2019
Decision Date May 14, 2019
Days to Decision 92 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
37d faster than avg
Panel avg: 129d · This submission: 92d
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 K190297.
STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader
K192025 · Advanced Sterilization Products (Asp) · Jan 2020
Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device
K192001 · Sterilucent, Inc. · Oct 2019
Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye
K191021 · Terragene S.A. · Sep 2019
CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack
K183294 · STERIS Corporation · Jan 2019
VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack
K183300 · Steris Corporations · Jan 2019
STERRAD VELOCITY Biological Indicator
K182404 · Advanced Sterilization Products (Asp) · Dec 2018