# K122555: Steritec Lead Free Sterilization Process Indicator Tape

- Pathway: 510(k) (Abbreviated)
- Applicant: Steritec Products Mfg Co, Inc.
- Decided: Dec 12, 2012 after 112 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 Green Tape can be used In 121 C gravity sterilizers for 30 minutes or pme-vacuum sterilizers operating at 1329C for4 minutes and 1350C for 3 minutes. Stripes turn black after exposure to steam steiliziation conditions, thus providing identification of processed items.

Source page: https://510kreport.com/device/K122555
Methodology: https://510kreport.com/methodology