Class Class II
Verifine® Pen Needles (K242632)
Description
Verifine® Pen Needles by Promisemed Hangzhou Meditech Co., Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242632
Clearance Date2024-09-26
Clearance TypeSpecial
Product CodeFMI
Regulation Number880.5570
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242632
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. Verifine® Pen Needles (K242632) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K161950 | Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2017 |
Trace the full predicate network for K242632
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.