# K951295: Sterrad Sterilization Pouch

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: May 19, 1995 after 58 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- 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
No predicates in its family tree.
28 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K103210: Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek Heat-Seal with Sterrad Chemical Indicators (2011), 15 descendants of its own
- K071087: Vis-U-All II Heat-Seal Pouch and Tubing (2007), 11 descendants of its own
- 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
- K090371: Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization System (2009), 9 descendants of its own

## Recalls of this device
- Jun 23, 2010 · Not classified · Z-1393-2011: The recall was initiated after Advanced Sterilization Products (ASP) discovered a non-conforming lot. The misaligned perforations may have caused the seal to be incomplete on some of the pouches, crea

Source page: https://510kreport.com/device/K951295
Methodology: https://510kreport.com/methodology