Cleared Special

K250061 - Celerity Incubator

K250061 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 Special 510(k) pathway after a 27-day FDA review.

K250061 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
27d
Days
Class 2
Risk

K250061 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 February 6, 2025 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K250061

510(k) Number K250061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2025
Decision Date February 06, 2025
Days to Decision 27 days
Submission Type Special
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
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 203
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K250061.
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
3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE
K243501 · 3M Company · Jan 2025
Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2)
K242453 · Terragene S.A. · Dec 2024
3M™ Attest™ Super Rapid Readout Biological Indicator 1493
K242538 · 3M Company · Nov 2024
K250061 · Celerity Incubator
Download PDF FDA Summary STERIS Corporation