Class Class II
Blood collection tube holders (K250961)
Description
Blood collection tube holders by Promisemed Hangzhou Meditech Co., Ltd., an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250961
Clearance Date2025-06-04
Clearance TypeTraditional
Product CodeJKA
Regulation Number862.1675
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250961
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. Blood collection tube holders (K250961) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230080 | Blood Collection Set, Blood Collection Set with Holder, Saf... | Yangzhou Medline Industry, Co., Ltd. | 2023 |
Trace the full predicate network for K250961
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.