510(k) Report

FDA applicant

Zerusa Limited

Galway, IE4 decisions2005–20102 recalls

FDA records 4 decisions for Zerusa Limited (Galway, IE) from 2005 to 2010: 4 510(k) clearances. All are in product code DTL (Adaptor, Stopcock, Manifold, Fitting…). Its devices cite 6 predicates, 4 of them its own earlier devices. 2 recalls are linked to its devices, 1 Class I.

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

FIG. A — Illustration, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2010

2008: 12009: 12010: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2013

2012: 12013: 1, 1 Class I
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Zerusa Limited by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass4decisions

Whose devices does it build on?

Its devices cite 6 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K092711Guardian II Hemostasis ValveZerusa Limited · 20093cite it
  • K073620Guardian Hemostasis ValveZerusa Limited · 20082cite it
  • K052381Guardian Hemostasis Valve with Guidewire IntroducerZerusa Limited · 20052cite it

What has FDA decided for it lately?

  • K101113Guardian II NC Hemostasis ValveZerusa Limited · 20101 Class I recall
  • K092711Guardian II Hemostasis ValveZerusa Limited · 20091 Class I recall
  • K073620Guardian Hemostasis ValveZerusa Limited · 2008
  • K052381Guardian Hemostasis Valve with Guidewire IntroducerZerusa Limited · 2005

All 4 as Zerusa Limited →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K092711Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in…Feb 27, 2013Class I
  • K092711Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model…Aug 30, 2012Class II