# K042426: TMD 0.5ML Safety Syringe (FA18 Series 0.5ML/FA58 Series U-100 Insulin/FA78 Series Tuberculin)

- Pathway: 510(k) (Special)
- Applicant: Taiject Medical Device Co., Ltd.
- Decided: Sep 22, 2004 after 14 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: 3 generations back to K022278 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031062: TMD 1ML Safety Syringe (FA11 Series 1ML/FA51 Series U-100 Insulin/FA71 Series Tuberculin), Taiject Medical Device Co., Ltd. (2003) Summary page 3.
- K022278: TMD Safety Syringe (FA12 Series 3ML/FA13 Series 5ML), Taiject Medical Device Co., Ltd. (2002) Summary page 3.

## Indications for use
The TMD T M 0.5ml Insulin Safety Syringe (FA58 Series U-100 Insulin) is intended for use for subcutaneous injection of Insulin. This syringe above incorporates a safety.feature that is designed to aid the reduction of needle stick injuries and the potential of syringe reuse. The TMD TM 0.5ml Safety Syringe (FA18 Series 0.5ml) is intended for injection of fluids into the body after the aspiration of fluid. The TMD TM 0.5ml Tuberculin Safety Syringe (FA78 Series Tuberculin) is intended intra-dermal of Tuberculin. All these two syringes above incorporate a safety feature that is designed to aid the reduction of needle stick injuries and the potential of syringe reuse.

Source page: https://510kreport.com/device/K042426
Methodology: https://510kreport.com/methodology