# K231996: Steriking® LT-Blueline Pouches with Tyvek®

- Pathway: 510(k) (Special)
- Applicant: Wipak OY
- Decided: Sep 7, 2023 after 64 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: 5 generations back to K921910 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221379: Steriking LT-Blueline Pouches with Tyvek, Wipak OY (2023) Summary page 6.

## Indications for use
Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERIS® V-Pro® Sterilizer Systems. The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 1 year post sterilization. The products are for single use only. Steriking® LT-Blueline Pouches with Tyvek® are intended for use in the following STERIS® V-Pro® Sterilization Cycles: Lumen Cycle Non Lumen Cycle Flexible Cycle Device lumen dimensions: Flexible Cycle: 1 lumen max and 1 mm min ID x 1050 mm max length for all pouch sizes. Lumen Cycle: 1 lumen max for all pouch sizes. 1 mm min ID for pouch sizes: 130 x 380 mm, 130 x 270 mm, 90 x 250 mm, 90 x 200 mm 2 mm min ID for pouch sizes: 300 x 450 mm, 250 x 400 mm, 190 x 330 mm 125 mm max length for pouch sizes: 130 x 380 mm, 130 x 270 mm, 90 x 250 mm, 90 x 200 mm 250 mm max length for pouch sizes: 300 x 450 mm, 250 x 400 mm, 190 x 330 mm Max Weights: 1.234 pounds for pouch sizes below (Flexible, Lumen, and Non-Lumen Cycles) 300 x 450 mm 250 x 400 mm 190 x 330 mm .122 pounds for pouch sizes below (Flexible and Lumen Cycles) 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm .204 pounds for pouch sizes below (Non-Lumen Cycle) 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm Pouch Sizes: 300 x 450 mm 250 x 400 mm 190 x 330 mm 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm

Source page: https://510kreport.com/device/K231996
Methodology: https://510kreport.com/methodology