Class Class II
Sterilization Pouch and Roll (K221875)
Description
Sterilization Pouch and Roll by Qianjiang Kingphar Medical Packaging & Printing Co., Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221875
Clearance Date2023-02-13
Clearance TypeTraditional
Product CodeFRG
Regulation Number880.6850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221875
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 Pouch and Roll (K221875) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212338 | SterileRight sterilization pouch and roll | Sterileright Packaging Mfg., Inc. | 2021 |
| K180661 | SIGMA Sterilization Pouch and Roll | Sigma Medical Supplies Corp. | 2018 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242898 | Sterilization Pouches and Reels | Shanghai Jianzhong Medical Packagin... | 2025 |
Trace the full predicate network for K221875
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.