# K052516: Steritec Container Cord - CI 135, Steritec Process Indicator Labels - CI 140, Steritec Process Indicator Dots - CI 137

- Pathway: 510(k) (Abbreviated)
- Applicant: Steritec Products, Inc.
- Decided: Oct 3, 2005 after 19 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
SteriTec Process Indicator Container Cards, Labels, and DOTS are intended for use by health care providers with steam sterilization wraps, container, cassettes, or pouches to distinguish between processed and unprocessed items. The Cards, Labels, and DOTS can be used in 1210 C gravity steam sterilizers or 132 - 1340 C pre-vacuum steam sterilizers. Indicators turn to dark gray/black after exposure to steam sterilization processes.

Source page: https://510kreport.com/device/K052516
Methodology: https://510kreport.com/methodology