# K023458: TMD Safety Syringe (FA14 Series 10ML/FA15 Series 20ML)

- Pathway: 510(k) (Special)
- Applicant: Taiject Medical Device Co., Ltd.
- Decided: Nov 7, 2002 after 23 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: 1 generation back to K022278 (2002). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022278: TMD Safety Syringe (FA12 Series 3ML/FA13 Series 5ML), Taiject Medical Device Co., Ltd. (2002) Summary page 1.

## Most influential descendants
- K031062: TMD 1ML Safety Syringe (FA11 Series 1ML/FA51 Series U-100 Insulin/FA71 Series Tuberculin) (2003), 1 descendant of its own
- K042426: TMD 0.5ML Safety Syringe (FA18 Series 0.5ML/FA58 Series U-100 Insulin/FA78 Series Tuberculin) (2004), 0 descendants of its own

## Indications for use
The TMDTM Safety Syringe (FA14 Series lOml/FA15 Series 20m1) is designed as an anti-stick syringe to reduce the risk of sharp injuries and the potential for syringe reuse and is a single use, disposable, manual retractable safety syringe which is intended for injection of fluids into and withdraw fluid from the body.

Source page: https://510kreport.com/device/K023458
Methodology: https://510kreport.com/methodology