# K190297: Celerity HP Incubator

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: May 14, 2019 after 92 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K004009 (2002). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171587: VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator, STERIS Corporation (2017) Summary page 5.

## Most influential descendants
- K213881: Celerity Incubator (2022), 3 descendants of its own
- K223715: Celerity Incubator (2023), 2 descendants of its own
- K250061: Celerity Incubator (2025), 0 descendants of its own
- K233681: ConFirm 20 Minute Incubator (2023), 0 descendants of its own

## Indications for use
Use the Celerity HP Incubator to incubate and automatically read Celerity 20 HP Biological Indicators at 57 °C for a fluorescent result within 20 minutes.

Source page: https://510kreport.com/device/K190297
Methodology: https://510kreport.com/methodology