# K001649: Steritec Autoclave Tapes, Model CI122 & CI1234

- Pathway: 510(k) (Abbreviated)
- Applicant: Steritec Products, Inc.
- Decided: Jun 23, 2000 after 24 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
No predicates in its family tree.
6 later devices descend from it; 1 cites 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K140940: Process Indicator Tape for Steam Sterilization (2014), 5 descendants of its own
- 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

Source page: https://510kreport.com/device/K001649
Methodology: https://510kreport.com/methodology