# K031062: TMD 1ML Safety Syringe (FA11 Series 1ML/FA51 Series U-100 Insulin/FA71 Series Tuberculin)

- Pathway: 510(k) (Special)
- Applicant: Taiject Medical Device Co., Ltd.
- Decided: May 2, 2003 after 29 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: 2 generations back to K022278 (2002). 2 ancestors in all.
1 later device descends 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 2.
- K023458: TMD Safety Syringe (FA14 Series 10ML/FA15 Series 20ML), Taiject Medical Device Co., Ltd. (2002) Summary page 3.

## Most influential descendants
- 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 TMD™ 1ml Safety Syringe (FA11 Series 1ml) is intended for injection of fluids into the body after the aspiration of fluid. The TMD™ 1ml Insulin Safety Syringe (FA51 Series U-100 Insulin) is intended for use for subcutaneous injection of Insulin. The TMD™ 1ml Tuberculin Safety Syringe (FA71 Series Tuberculin) is intended for intra-dermal injection of Tuberculin. All the three syringes above incorporate a safety feature that is designed to aid the reduction of needlestick injuries and the potential of syringe reuse.

Source page: https://510kreport.com/device/K031062
Methodology: https://510kreport.com/methodology