Tmd 1ml Safety Syringe (FA11 Series 1ml/FA51 Series U-100 Insulin/FA71 Series Tuberculin)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K031062 ↗

FDA Product Code

MEG

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Tmd 0.5ml Safety Syringe (FA18 Series 0.5ml/FA58 Series U-100 Insulin/FA78 Series Tuberculin)

  Class II

  FDA 510(k) K042426 Active Cleared 22 Sep 2004

• Tmd Safety Syringe (FA12 Series 3ml/FA13 Series 5ml)

  Class II

  FDA 510(k) K022278 Active Cleared 12 Sep 2002

• Tmd Safety Syringe (FA14 Series 10ml/FA15 Series 20ml)

  Class II

  FDA 510(k) K023458 Active Cleared 7 Nov 2002

• What is the TMD 1ML Safety Syringe used for?

  The TMD 1ML Safety Syringe is used in clinical settings by healthcare providers or patients for insulin or tuberculin administration, delivering a fluid dose via manual activation of the safety feature post-injection.

• Is the TMD 1ML Safety Syringe sterile and single-use?

  Yes, the TMD 1ML Safety Syringe is supplied sterile and intended for single-use only, as stated in its description, to ensure infection control and prevent reuse.

• What safety feature does the TMD 1ML Safety Syringe have?

  The TMD 1ML Safety Syringe is a manual retractable syringe designed to reduce sharps injuries by activating the safety feature after injection, which retracts the needle to prevent accidental sticks.

• What regulatory clearance does the TMD 1ML Safety Syringe have?

  The TMD 1ML Safety Syringe has FDA 510(k) clearance under K031062 and is classified under product code MEG, indicating it is substantially equivalent to a legally marketed device.