# K161024: Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape

- Pathway: 510(k) (Special)
- Applicant: Canadian Technical Tape, Ltd.
- Decided: Jun 28, 2016 after 77 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 K001649 (2000). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 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.

## Most influential descendants
- K260181: LF Process Indicator Tape for Steam Sterilization (2026), 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 Canadian Technical Tape, Ltd. LF 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 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/K161024
Methodology: https://510kreport.com/methodology