# K191639: TK Insulin Syringe with/without Saftey Retractable Device

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Tiankang Medical Technology Co., Ltd.
- Decided: Sep 11, 2020 after 450 days
- Product code: MEG (Syringe, Antistick)
- 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: 6 generations back to K000572 (2000). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152808: U&U Insulin Syringe with/without Safety Retractable Device, U&U Medical Technology Co, Ltd. (2016) Summary page 4.

## Indications for use
The TK Insulin Syringe with Safety Retractable Device is a sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse. The TK Insulin Syringe is a sterile, single-use, disposable and non-reusable, insulin syringe intended for injection of U-100 insulin into the body.

Source page: https://510kreport.com/device/K191639
Methodology: https://510kreport.com/methodology