Class Class II
Disposable Pen Injector Assembly (K240961)
Description
Disposable Pen Injector Assembly by Wuxi Nest Biotechnology Co., Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240961
Clearance Date2024-08-15
Clearance TypeTraditional
Product CodeFMF
Regulation Number880.5860
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240961
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. Disposable Pen Injector Assembly (K240961) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182387 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injec... | Novo Nordisk, Inc. | 2018 |
Trace the full predicate network for K240961
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.