Class Class II
Safety Winged Blood Collection Sets (K243806)
Description
Safety Winged Blood Collection Sets by Promisemed Hangzhou Meditech Co., Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243806
Clearance Date2025-01-10
Clearance TypeSpecial
Product CodeFMI
Regulation Number880.5570
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243806
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. Safety Winged Blood Collection Sets (K243806) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211293 | Safety Winged Blood Collection Sets | Promisemed Hangzhou Meditech Co., Ltd. | 2021 |
Trace the full predicate network for K243806
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.