Class Class II
Celerity Incubator (K250061)
Description
Celerity Incubator by STERIS Corporation, an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250061
Clearance Date2025-02-06
Clearance TypeSpecial
Product CodeFRC
Regulation Number880.2800
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250061
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Celerity Incubator (K250061) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223715 | Celerity Incubator | STERIS Corporation | 2023 |
Trace the full predicate network for K250061
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.