# K103210: Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek Heat-Seal with Sterrad Chemical Indicators

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Jun 6, 2011 after 217 days
- Product code: FRG (Wrap, Sterilization)
- 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: 1 generation back to K921910 (1993). 2 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951295: Sterrad Sterilization Pouch, Advanced Sterilization Products (1995) Summary page 1.
- K921910: Sterrad Chemical Indicator, Johnson & Johnson Medical, Inc. (1993) Summary page 1.

## Most influential descendants
- K133838: Sterilization Pouch/Roll Made with Tyvek (2015), 10 descendants of its own
- K180672: Sterilization Pouch/Roll Made with Tyvek (2018), 9 descendants of its own
- K212198: Tyvek (R) Roll with CI for STERLINKTM Sterilizer (2021), 3 descendants of its own
- K112087: Tyvek Self-Seal Pouches ,Tyvek Heat-Seal Rolls (2012), 2 descendants of its own
- K221379: Steriking LT-Blueline Pouches with Tyvek (2023), 1 descendant of its own

## 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® 100NX™ Sterilizer 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 seal of the pouch/roll is opened. 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/K103210
Methodology: https://510kreport.com/methodology