# K111518: Sterrad Chemial Indicator Strip Model 14100

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Oct 3, 2012 after 489 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.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103218: Sterrad Chemical Indicator Strip, Advanced Sterilization Products (2011) Summary page 1.

## Most influential descendants
- K234084: STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count) (2024), 0 descendants of its own

## Indications for use
The STERRAD® Chemical Indicator Strip (PN 14100) is a process indicator (ISO 11140-1:2005) to differentiate processed from unprocessed packages and is intended for use with medical device packages to be sterilized in STERRAD® Sterilization Systems: MODEL CYCLE STERRA Dt lOGS Standard STERRADY50 Standard STERRAD® 200 Standard Standard STERRAD® NX® Advanced Standard STERRAD® IOONX® Flex EXPRESS ___________ DUO

Source page: https://510kreport.com/device/K111518
Methodology: https://510kreport.com/methodology