# K191741: Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape

- Pathway: 510(k) (Special)
- Applicant: Intertape Polymer, Inc.
- Decided: Aug 2, 2019 after 32 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: 3 generations back to K001649 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140940: Process Indicator Tape for Steam Sterilization, Canadian Technical Tape, Ltd. (2014) Summary page 4.
- K161024: Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape, Canadian Technical Tape, Ltd. (2016) Summary page 4.

## Indications for use
The Bismuth Process Indicator Steam Sterilization Tape is indicated for use in holding sterilization packs together and can be used in gravity sterilizers operating at 121°C for 30 minutes; 132 °C for 3 minutes; 132 °C for 10 minutes; 132 °C for 15 minutes; 135 °C for 3 minutes and 135 °C for 10 minutes or pre-vacuum sterilizers operating at 132°C for 3 minutes; 132 °C for 4 minutes; 134 °C for 3 minutes; 134 °C for 4 minutes and 135°C for 3 minutes. The indicator lines turn dark brown/black when exposed to steam sterilization conditions, thus providing an indication of processed items.

Source page: https://510kreport.com/device/K191741
Methodology: https://510kreport.com/methodology