# K250733: 3DOSE 1ml Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Bimed Teknik Aletler Sanayi & Ticaret A.S.
- Decided: Jul 3, 2025 after 114 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K980987 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191642: TK Sterile Piston Syringe without Needle, Anhui Tiankang Medical Technology Co., Ltd. (2020) Summary page 5.

## Indications for use
The 3 DOSE 1 ml Syringe is intended for use by health care professionals for general purpose fluid aspiration/ injection.

Source page: https://510kreport.com/device/K250733
Methodology: https://510kreport.com/methodology