# K140566: Spsmedical VH2O2 Indicator Strips, Indicator Labels, Indicator Tape

- Pathway: 510(k) (Traditional)
- Applicant: Crosstex International
- Decided: Nov 24, 2014 after 264 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: 4 generations back to K921910 (1993). 4 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110152: Spsmedical Vaporized Hydrogen Peroxide Chemical Indicators, Spsmedical Supply Corp. (2011) Summary page 4.

## Most influential descendants
- K200096: Crosstex VH2O2 Chemical Indicators (2021), 0 descendants of its own
- K191999: Sterilucent VH2O2 Chemical Indicators (2019), 0 descendants of its own
- K143520: SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label) (2015), 0 descendants of its own

## Indications for use
A chemical indicator for monitoring all cycles within the STERRAD ® 100S (Standard & Long), 200, 100NX (Standard, Flex & Express), NX (Standard & Advanced), STERIS® V-PRO™ 1, V-PRO™ 1 Plus (Lumen & Non-lumen), V-PRO® maX (Flexible, Lumen & Non-lumen) and Sterilucent™ PSD-85 (Lumen & Non-lumen). The VH2O2 Indicators are intended to be used by health care providers with sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed units. Colors other than blue such as yellow/green should be treated as a process failure.

Source page: https://510kreport.com/device/K140566
Methodology: https://510kreport.com/methodology