Class Class II
Promisemed Safety Huber Needles (K251138)
Description
Promisemed Safety Huber Needles by Promisemed Hangzhou Meditech Co., Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251138
Clearance Date2025-05-13
Clearance TypeSpecial
Product CodePTI
Regulation Number880.5570
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251138
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. Promisemed Safety Huber Needles (K251138) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243332 | Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2025 |
Trace the full predicate network for K251138
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.