# K140940: Process Indicator Tape for Steam Sterilization

- Pathway: 510(k) (Traditional)
- Applicant: Canadian Technical Tape, Ltd.
- Decided: Oct 27, 2014 after 196 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 K001649 (2000). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001649: Steritec Autoclave Tapes, Model CI122 & CI1234, Steritec Products, Inc. (2000) Summary page 4.

## Most influential descendants
- K161024: Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape (2016), 2 descendants of its own
- K210553: Steam-Dot Process Indicator (2021), 1 descendant of its own
- K260181: LF Process Indicator Tape for Steam Sterilization (2026), 0 descendants of its own
- K241036: Autoclave Indicator Tape; EO Indicator Tape (2024), 0 descendants of its own
- K191741: Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape (2019), 0 descendants of its own

## Indications for use
The Process Indicator Tape for Steam Sterilization is indicated for use in holding sterilization packs together and can be used in gravity sterilizers operating at 121°C for 30 minutes or pre-vacuum sterilizers operating at 132°C for 4 minutes and 135°C for 3 minutes. The indicator stripes turn dark brown/black when exposed to steam sterilization conditions, thus providing an indication of processed items.

Source page: https://510kreport.com/device/K140940
Methodology: https://510kreport.com/methodology