# K172753: VERIFY VH2O2 Indicator Tape

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Feb 9, 2018 after 150 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: 5 generations back to K022441 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160485: VERIFY VH2O2 Indicator Tape, STERIS Corporation (2016) Summary page 5.

## Indications for use
The VERIFY™ VH2O2 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) to peach, yellow or lighter. The VERIFY™ VH2O2 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: • Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Sterilizers • Standard Cycle of the STERRAD® 100S Sterilizer • Standard and Advanced Cycles of the STERRAD® NX Sterilizer • Express, Flex Scope, Duo and Standard Cycles of the STERRAD® 100 NX Sterilizer

Source page: https://510kreport.com/device/K172753
Methodology: https://510kreport.com/methodology