# K030680: Spsmedical Gas Plasma Chemical Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Spsmedical Supply Corp.
- Decided: May 9, 2003 after 65 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: 1 generation back to K921910 (1993). 1 ancestor in all.
6 later devices descend from it; 2 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)
- K921910: Sterrad Chemical Indicator, Johnson & Johnson Medical, Inc. (1993) Summary page 1.

## Most influential descendants
- K090650: Spsmedical Vaporized Hydrogen Peroxide Chemical Indicators (2009), 5 descendants of its own
- 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

## Indications for use
The SPSmedical Gas Plasma Chemical Indicators are indicated for use as process indicators to verify exposure to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S and STERRAD® 50 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 item. Indicators change to a signal color of BLUE after exposure to vapor hydrogen peroxide in these sterilization processes.

Source page: https://510kreport.com/device/K030680
Methodology: https://510kreport.com/methodology