# K231999: 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)
- K221377: SteriKing LT-Blueline Pouches with Tyvek, Wipak OY (2022) Summary page 5.

## 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 STERRAD® 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 years post sterilization. The products are for single use only. The Steriking® LT-Blueline Pouches with Tyvek are intended for use in the following STERRAD® Sterilization Cycles: NX Standard NX Advanced 100NX Duo 100NX Flex 100NX Standard Max weights: NX Standard Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .094 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.194 pounds. NX Advanced Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .096 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.224 pounds. 100NX Duo Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .116 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.222 pounds. 100NX Flex Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .202 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.220 pounds. 100NX Standard Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .202 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 4.478 pounds. Max Count of lumens: 1 lumen max for All cycles Max ID of lumens: NX Standard Cycle: 1 mm ID for all pouch sizes NX Advanced Cycle: 2 mm ID for all pouch sizes 100NX Cycle: 1 mm ID for all pouch sizes 100NX Flex Cycle: 1 mm ID for all pouch sizes 100NX Standard Cycle: 2 mm ID for all pouch sizes Max lumen lengths: NX Standard Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, 125 mm. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 250 mm. NX Advanced Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, 125 mm. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 250 mm. 100NX Duo Cycle: 850 mm for all pouch sizes 100NX Flex Cycle: 850 mm for all pouch sizes 100NX Standard Cycle: For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, 125 mm. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 250 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/K231999
Methodology: https://510kreport.com/methodology