# K173626: Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Feb 21, 2018 after 89 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K926364 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121593: 3M Attest (TM) Super Radid Readout Steam Challenge Pack 3M Attest (TM) Super Rapid 5 Steam-Plus Challenge Pack, 3M Company (2013) Summary page 5.

## Recalls of this device
- May 25, 2022 · Class III · Z-1793-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

## Indications for use
The Celerity™ 20 Steam Challenge Pack is used for qualification, routine microbial monitoring, and load monitoring of steam sterilizers. The validated steam sterilization cycles include: • 270°F (132°C) 4-minute dynamic air removal (Prevac, SFPP) • 275°F (135°C) 3-minute dynamic air removal (Prevac, SFPP)

Source page: https://510kreport.com/device/K173626
Methodology: https://510kreport.com/methodology