Class Class II
Steriking LT-Blueline Pouches with Tyvek (K221379)
Description
Steriking LT-Blueline Pouches with Tyvek by Wipak OY, an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221379
Clearance Date2023-01-04
Clearance TypeTraditional
Product CodeFRG
Regulation Number880.6850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221379
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Steriking LT-Blueline Pouches with Tyvek (K221379) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K180672 | Sterilization Pouch/Roll Made with Tyvek | Sigma Medical Supplies Corporation | 2018 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231996 | Steriking® LT-Blueline Pouches with Tyvek® | Wipak OY | 2023 |
Trace the full predicate network for K221379
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.