# K163598: Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Jul 31, 2017 after 222 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K921910 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141693: Tyvek® Pouch/Roll with STERRAD® Chemical Indicator, Advanced Sterilization Products (2014) Summary page 4.

## 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 is intended to maintain sterility of the enclosed device until used. The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2014 [Type I]) that changes from red to the color indicated on the comparator bar included on the shelf pack (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD Sterilization Systems. The pouches and rolls can be used in the STERRAD Sterilization Systems and Cycles shown in Table 1.

Source page: https://510kreport.com/device/K163598
Methodology: https://510kreport.com/methodology