Celerity Incubator
K-Number: K250061 · 2025-02-06
ApplicantSTERIS Corporation
Decision Date2025-02-06
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Celerity Incubator is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2025-02-06 under approval number K250061. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Celerity Incubator?
Celerity Incubator is a medical device that received FDA 510(k) clearance on 2025-02-06. It is manufactured by STERIS Corporation. The 510(k) number is K250061.
When was Celerity Incubator approved by the FDA?
Celerity Incubator received FDA 510(k) clearance on 2025-02-06, under approval number K250061.
What company makes Celerity Incubator?
Celerity Incubator is manufactured by STERIS Corporation.
What is the FDA product code for Celerity Incubator?
The FDA product code for Celerity Incubator is FRC.
Other Devices by STERIS Corporation
Related Devices (Code: FRC)
K1605463M Attest Rapid Readout Biological Indicator3M Company
K151482BCR-30-min BI and RBIP-ST30 Readout AccessoryBcr Diagnostics, Inc.
K172474Celerity 20 HP Biological IndicatorSTERIS Corporation
K172432SporView Rapid Read Biological IndicatorCrosstex/Spsmedical, A Division of Cantel Medical
K163646Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader IncubatorTerragene S.A.
K170427Anprolene SteriTestAndersen Sterilizers, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.