# K141693: Tyvek® Pouch/Roll with STERRAD® Chemical Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Dec 19, 2014 after 178 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K921910 (1993). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112087: Tyvek Self-Seal Pouches ,Tyvek Heat-Seal Rolls, Advanced Sterilization Products (2012) Summary page 5.

## Most influential descendants
- K163598: Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator (2017), 0 descendants of its own

## Recalls of this device
- Dec 24, 2014 · Class II · Z-1312-2015: Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because they were shipped to customers after its expiration date of May 18, 2013.

## Indications for use
Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD® Sterilization Systems and Cycles, in a single or double pouch configuration, and to indicate, by color change, that the pouch has been exposed to sterilant. After completion of the sterilization process, the pouch/roll maintains sterility until the pouch/roll is used; in the United States, this is for a period of 30 days. The STERRAD® Sterilization Systems and Cycles that can be used are shown in Table 1. The product codes for all Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are listed in Table 2. The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to yellow (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization Systems.

Source page: https://510kreport.com/device/K141693
Methodology: https://510kreport.com/methodology