# K132120: WTF Secura Syringe and Needle

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Wantefu Medical Apparatus Co., Ltd.
- Decided: Dec 12, 2013 after 156 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: 2 generations back to K980069 (1998). 4 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023752: BD Integra Syringe, Bd (2003) Summary page 2.

## Most influential descendants
- K143497: Safety Auto-Disable Syrine with Needle (Auto-Lock) (2015), 3 descendants of its own
- K231727: Sterile Auto-Disable Syringes with/without Needle for Single Use (2023), 0 descendants of its own
- K221981: SafeR Syringe and SafeR Sting (2022), 0 descendants of its own
- K210229: Sterile Auto-Disable Syringes with/without Needle for Single Use (2022), 0 descendants of its own
- K211210: Sterile Auto-Disable Syringes with/without Needle for Single Use (2022), 0 descendants of its own

## Indications for use
The WTF Secure Syringe (with needle) is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the suface of the skin. The WTF Secure Syringe (with needle) has a manually attached WTP Secura Retracting Needle. The WiT Secure Syringe (with needle) contains an inner mechanism used to allow the WTF Secure Retracting Needle to be retracted inside the plunger rod of the syringe when opematoes thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

Source page: https://510kreport.com/device/K132120
Methodology: https://510kreport.com/methodology