# K260181: LF Process Indicator Tape for Steam Sterilization

- Pathway: 510(k) (Special)
- Applicant: Intertape Polymer Group
- Decided: Feb 20, 2026 after 30 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)
- K161024: Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape, Canadian Technical Tape, Ltd. (2016) Summary page 5.

## Indications for use
The LF Process Indicator Tape for Steam Sterilization is designed to use on disposable wraps for sealing packs that are exposed to steam sterilization. The tape distinguishes between items processed and unprocessed in both gravity discharge and pre-vacuum steam sterilization processes. It is intended for use 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. 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 green indicator lines turn dark brown/black once exposed to the steam process.

Source page: https://510kreport.com/device/K260181
Methodology: https://510kreport.com/methodology