510(k) Report

FDA applicant

Unilife Medical Solutions Limited

Lewisberry, PA3 decisions2008–20100 recalls

FDA records 3 decisions for Unilife Medical Solutions Limited (Lewisberry, PA) from 2008 to 2010: 3 510(k) clearances. Most are in product codes MEG (Syringe, Antistick) and FMF (Syringe, Piston). Its devices cite 5 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Unilife Medical Solutions Limited’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2008: 12010: 2
2008high 2 (2010) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Unilife Medical Solutions Limited by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Unilife Medical Solutions Limited’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MEGSyringe, Antistick2decisions
  • FMFSyringe, Piston1decision

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K0808771ML Unitract Insulin Syringe 27G*1/2 , 1ML Unitract Syringe 29G*1/2Unilife Medical Solutions Limited · 20081cites it
  • K0934001ML Unitract Insulin Syringe 27G X 1/2 and 29G X 1/2Unilife Medical Solutions Limited · 20101cites it

What has FDA decided for it lately?

  • K1009981ML Unitract 27G X 1/2 Tuberculin Syringe, Model 132BY2-1Unilife Medical Solutions Limited · 2010
  • K0934001ML Unitract Insulin Syringe 27G X 1/2 and 29G X 1/2Unilife Medical Solutions Limited · 2010
  • K0808771ML Unitract Insulin Syringe 27G*1/2 , 1ML Unitract Syringe 29G*1/2Unilife Medical Solutions Limited · 2008

All 3 as Unilife Medical Solutions Limited →