Class Class II
3DOSE 1ml Syringe (K250733)
Description
3DOSE 1ml Syringe by Bimed Teknik Aletler Sanayi & Ticaret A.S., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250733
Clearance Date2025-07-03
Clearance TypeTraditional
Product CodeFMF
Regulation Number880.5860
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250733
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. 3DOSE 1ml Syringe (K250733) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K191642 | TK Sterile Piston Syringe without Needle | Anhui Tiankang Medical Technology C... | 2020 |
Trace the full predicate network for K250733
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.