# K132291: Namsa Chemical Process

- Pathway: 510(k) (Traditional)
- Applicant: North American Science Assoc., Inc.
- Decided: May 20, 2014 after 301 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: 1 generation back to K951113 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951113: Cross-Checks, Steritec Products Mfg Co, Inc. (1996) Summary page 1.

## Indications for use
The NAMSA Chemical Process Indicator Strip for Steam, REF TST4-S Is intended for use with individual materials (i.e. pouches, pack, tray) to demonstrate that the material has been exposed to a steam sterilization process to distinguish between processed and unprocessed goods. The NAMSA Chemical Process Indicator Strip for Steam will transition from an initial yellow color to a dark brown/black signal color when exposed to high temperature steam at the following time and temperature intervals as a process indicator: * 1210C for 30 minutes (gravity cycle) *1 34*C for 3 minutes (pre-vacuum cycle)

Source page: https://510kreport.com/device/K132291
Methodology: https://510kreport.com/methodology