# K242189: CELERITY HP Indicator Tape (PCC077)

- Pathway: 510(k) (Special)
- Applicant: Steris
- Decided: Aug 20, 2024 after 26 days
- Product code: JOJ (Indicator, Physical/Chemical 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: 10 generations back to K921910 (1993). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240760: CELERITY HP Indicator Tape, Steris (2024) Summary page 5.

## Indications for use
The Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink/magenta) to orange, yellow or lighter. The Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches. The tape may be used in the following sterilization cycles: • Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO: 1, 1 Plus, max, max 2, 60, and s2 Low Temperature Sterilization Systems. • Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear

Source page: https://510kreport.com/device/K242189
Methodology: https://510kreport.com/methodology