510(k) Report

FDA applicant

Leventon, S.A.

Barcelona, ES5 decisions1985–20051 recall

FDA records 5 decisions for Leventon, S.A. (Barcelona, ES) from 1985 to 2005: 5 510(k) clearances. Most are in product codes BWF (Spirometer, Therapeutic (Incentive)) and FPA (Set, Administration, Intravascular). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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 Leventon, S.A.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Leventon, S.A. since 2007.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Leventon, S.A. 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?

  • BWFSpirometer, Therapeutic (Incentive)2decisions
  • FPASet, Administration, Intravascular1decision
  • LDRController, Infusion, Intravascular, Electronic1decision
  • MEBPump, Infusion, Elastomeric1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K952810Dosi-Flow, Models 20 & 30Leventon, S.A. · 19951cites it

What has FDA decided for it lately?

  • K053149Spiro-BallLeventon, S.A. · 2005
  • K040752Dosi-FuserLeventon, S.A. · 2004
  • K994074Tri-BallLeventon, S.A. · 2000
  • K952810Dosi-Flow, Models 20 & 30Leventon, S.A. · 1995
  • K851058Dosi FlowLeventon, S.A. · 19851 recall

All 5 as Leventon, S.A. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K851058"***DOSI-FLOW 1 I.V. EXTENSION SET WITH I.V. FLOW REGULATOR REGULADOR DE CAUDAL PARA…Mar 11, 2011