# K191642: TK Sterile Piston Syringe without Needle

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Tiankang Medical Technology Co., Ltd.
- Decided: Jan 6, 2020 after 201 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: 3 generations back to K980987 (1998). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132553: U&U Sterile Piston Syringe Without Needle, U&U Medical Technology Co, Ltd. (2014) Summary page 4.

## Most influential descendants
- K250733: 3DOSE 1ml Syringe (2025), 0 descendants of its own

## Indications for use
TK Sterile Piston Syringes is intended for use by health care professionals for general purpose fluid aspiration/ injection.

Source page: https://510kreport.com/device/K191642
Methodology: https://510kreport.com/methodology