# K100998: 1ML Unitract 27G X 1/2 Tuberculin Syringe,  Model 132BY2-1

- Pathway: 510(k) (Traditional)
- Applicant: Unilife Medical Solutions Limited
- Decided: Aug 30, 2010 after 140 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: 4 generations back to K980069 (1998). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093400: 1ML Unitract Insulin Syringe 27G X 1/2 and 29G X 1/2, Unilife Medical Solutions Limited (2010) Summary page 1.
- K023752: BD Integra Syringe, Bd (2003) Summary page 1.

## Indications for use
The Unitract Tuberculin Syringe, as supplied, is a device with a small barrel, plunger, and fixed needle, calibrated in milliliters (0.01 increments) to be used to administer (infuse) medication subcutaneous, intramuscular, or intradermal. It incorporates features that include reuse prevention (auto-disable) and sharps injury prevention (automatic needle retraction).

Source page: https://510kreport.com/device/K100998
Methodology: https://510kreport.com/methodology