# K090650: Spsmedical Vaporized Hydrogen Peroxide Chemical Indicators

- Pathway: 510(k) (Traditional)
- Applicant: Spsmedical Supply Corp.
- Decided: Oct 9, 2009 after 212 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: 2 generations back to K921910 (1993). 2 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K030680: Spsmedical Gas Plasma Chemical Indicator, Spsmedical Supply Corp. (2003) Summary page 1.

## Most influential descendants
- K110152: Spsmedical Vaporized Hydrogen Peroxide Chemical Indicators (2011), 4 descendants of its own
- K140566: Spsmedical VH2O2 Indicator Strips, Indicator Labels, Indicator Tape (2014), 3 descendants of its own
- 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
The SPSmedical H 20 2 Chemical Indicators are indicated for use as process indicators for all vaporized hydrogen peroxide cycles in the STERRAD® 100S, 200, 100NX, NX and STERIS® V-Pro sterilization processes. They are intended to be used by health care providers with articles such as sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed items. Indicators change to a signal color of Blue after exposure to vapor hydrogen peroxide.

Source page: https://510kreport.com/device/K090650
Methodology: https://510kreport.com/methodology