510(k) Report

FDA applicant

Fogless International AB

Vaggeryd, SE1 decision2013–20130 recalls

FDA records 1 decision for Fogless International AB (Vaggeryd, SE) in 2013: 1 510(k) clearance. All are in product code JOH (Tube Tracheostomy And Tube Cuff). 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2013

2013: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Fogless International AB by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fogless International AB’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?

  • JOHTube Tracheostomy And Tube Cuff1decision

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.

  • K122932Spiro Speaking Valve with Oxygen Port Spiro Speaking Valve Without Oxygen PortFogless International AB · 20131cites it

What has FDA decided for it lately?

  • K122932Spiro Speaking Valve with Oxygen Port Spiro Speaking Valve Without Oxygen PortFogless International AB · 2013

The one decision as Fogless International AB →