# K191999: Sterilucent VH2O2 Chemical Indicators

- Pathway: 510(k) (Traditional)
- Applicant: Sterilucent, Inc.
- Decided: Oct 21, 2019 after 87 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 K921910 (1993). 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)
- K140566: Spsmedical VH2O2 Indicator Strips, Indicator Labels, Indicator Tape, Crosstex International (2014) Summary page 4.
- K110152: Spsmedical Vaporized Hydrogen Peroxide Chemical Indicators, Spsmedical Supply Corp. (2011) Summary page 4.

## Indications for use
A chemical indicator for monitoring all cycles within the Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer (Lumen & Flexible), STERRAD® 100S (Standard & Long), 200, 100NX (Standard, Flex & Express), NX (Standard & Advanced), STERIS® VPRO™ 1, V-PRO™ 1 Plus (Lumen & Non-Lumen), VPRO® 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/K191999
Methodology: https://510kreport.com/methodology