# K220204: Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Tiankang Medical Technology Co., Ltd.
- Decided: Jul 14, 2022 after 170 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: 8 generations back to K771205 (1977). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192551: 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle, Jiangsu Caina Medical Co.,Ltd (2020) Summary page 5.

## Indications for use
The Disposable Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential of syringe reuse.

Source page: https://510kreport.com/device/K220204
Methodology: https://510kreport.com/methodology