# K093400: 1ML Unitract Insulin Syringe 27G X 1/2 and 29G X 1/2

- Pathway: 510(k) (Special)
- Applicant: Unilife Medical Solutions Limited
- Decided: Apr 1, 2010 after 150 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: 3 generations back to K980069 (1998). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080877: 1ML Unitract Insulin Syringe 27G*1/2 , 1ML Unitract Syringe 29G*1/2, Unilife Medical Solutions Limited (2008) Summary page 1.

## Most influential descendants
- K100998: 1ML Unitract 27G X 1/2 Tuberculin Syringe,  Model 132BY2-1 (2010), 0 descendants of its own

## Indications for use
The syringe, as supplied, is a device with a small barrel, plunger and fixed needle, calibrated in units of insulin (U-100), to be used to administer (infuse) insulin subcutaneously. It incorporates features that include reuse prevention and sharps injury prevention.

Source page: https://510kreport.com/device/K093400
Methodology: https://510kreport.com/methodology