510(k) Report

FDA applicant

Atos Medical AB

Horby, SE15 decisions1990–20160 recalls

FDA records 15 decisions for Atos Medical AB (Horby, SE) from 1990 to 2016: 15 510(k) clearances. Most are in product codes EWL (Prosthesis, Laryngeal (Taub)) and JOH (Tube Tracheostomy And Tube Cuff). Its devices cite 14 predicates, 8 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, ear, nose and throat panel, where it files most

How often FDA has decided Atos Medical AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2008: 12009: 12010: 12013: 12014: 12016: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • EWLProsthesis, Laryngeal (Taub)8decisions
  • JOHTube Tracheostomy And Tube Cuff3decisions
  • KAMCannula, Sinus3decisions
  • ETDTube, Tympanostomy1decision

Whose devices does it build on?

Its devices cite 14 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 8 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.

  • K971244Provox 2 Voice Prosthesis SystemAtos Medical AB · 19973cite it
  • K022125Provox Freehands Hme, Model 7710Atos Medical AB · 20022cite it
  • K014102Provox Hme Cassette, Model 7240; Provox Adhesive, Model 7251Atos Medical AB · 20022cite it
  • K131947Provox Vega Puncture SetAtos Medical AB · 20131cites it
  • K090455Provox Vega, Model 8130-8135Atos Medical AB · 20091cites it
  • K940638Provox (TM) Voice ProsthesisAtos Medical AB · 19941cites it

What has FDA decided for it lately?

  • K151404ProTrach DualcareAtos Medical AB · 2016
  • K141380Provox Freehands FlexivoiceAtos Medical AB · 2014
  • K131947Provox Vega Puncture SetAtos Medical AB · 2013
  • K092593Provox Activalve (Size 4.5MM, 6MM, 8MM, 10MM, 12.5MM)Atos Medical AB · 2010
  • K090455Provox Vega, Model 8130-8135Atos Medical AB · 2009
  • K072582Provox Micron HmeAtos Medical AB · 2008
  • K043138Provox Nid Voice Rehabilitation System, Model Ref 7101 to 7134Atos Medical AB · 2004
  • K022125Provox Freehands Hme, Model 7710Atos Medical AB · 2002

All 15 as Atos Medical AB →