# K221377: SteriKing LT-Blueline Pouches with Tyvek

- Pathway: 510(k) (Traditional)
- Applicant: Wipak OY
- Decided: Dec 22, 2022 after 224 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: 4 generations back to K921910 (1993). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180672: Sterilization Pouch/Roll Made with Tyvek, Sigma Medical Supplies Corporation (2018) Summary page 5.

## Most influential descendants
- K231999: Steriking® LT-Blueline Pouches with Tyvek® (2023), 0 descendants of its own

## Indications for use
The SteriKing® LT Blueline with Tyvek® pouches 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 3 years post sterilization. The products are for single use only. The SteriKing® LT Blueline with Tyvek® pouches 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: 75 mm x 200 mm, 100 mm x 250 mm, 150 mm x 300 mm, 160 mm x 440 mm, 160 mm x 600 mm: .088 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.382 pounds NX Advanced Cycle: 75 mm x 200 mm, 100 mm x 250 mm, 150 mm x 300 mm, 160 mm x 440 mm, 160 mm x 600 mm: .084 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.393 pounds 100NX Duo Cycle: 75 mm x 200 mm, 100 mm x 250 mm, 150 mm x 300 mm, 160 mm x 440 mm, 160 mm x 600 mm: .104 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.400 pounds 100NX Flex Cycle: 75 mm x 200 mm, 100 mm x 250 mm, 150 mm x 300 mm, 160 mm x 440 mm, 160 mm x 600 mm: .158 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 1.400 pounds 100NX Standard Cycle: 75 mm x 200 mm, 100 mm x 250 mm, 150 mm x 300 mm, 160 mm x 440 mm, 160 mm x 600 mm: .158 pounds 205 mm x 390 mm, 250 mm x 390 mm, 250 mm x 500 mm: 4.476 pounds Max lumens: 1 mm min ID and Max 1 lumen. for all cycles NX Standard Cycle: For pouch sizes 250x500mm, 250x390mm, 205x390mm is 125 mm max length. Max length is 50 mm for all other pouch sizes. NX Advanced Cycle: For pouch sizes 250x500mm, 250x390mm, 205x390mm is 125 mm max length. Max length is 50 mm for all other pouch sizes. 100NX Duo Cycle: For pouch sizes 250x500mm, 250x390mm, 205x390mm is 875 mm max length. Max length is 850 mm for all other pouch sizes. 100NX Flex Cycle: Max length is 850 mm for all pouch sizes. 100NX Standard Cycle: For pouch sizes 250x500mm, 250x390mm, 205x390mm is 125 mm max length. Max length is 50 mm for all other pouch sizes. Pouch Sizes: 250 mm x 500 mm 250 mm x 390 mm 205 mm x 390 mm 160 mm x 600 mm 160 mm x 440 mm 150 mm x 300 mm 100 mm x 250 mm 75 mm x 200 mm

Source page: https://510kreport.com/device/K221377
Methodology: https://510kreport.com/methodology