Class Class II
Sterilization Pouches and Reels (K242898)
Description
Sterilization Pouches and Reels by Shanghai Jianzhong Medical Packaging Co., Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242898
Clearance Date2025-02-21
Clearance TypeTraditional
Product CodeFRG
Regulation Number880.6850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242898
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. Sterilization Pouches and Reels (K242898) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221875 | Sterilization Pouch and Roll | Qianjiang Kingphar Medical Packagin... | 2023 |
Trace the full predicate network for K242898
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.