510(k) Report

FDA applicant

Ekom S.R.O.

Dana Point, CA2 decisions2006–20090 recalls

FDA records 2 decisions for Ekom S.R.O. (Dana Point, CA) from 2006 to 2009: 2 510(k) clearances. All are in product code BTI (Compressor, Air, Portable). Its devices cite 3 predicates, 1 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, anesthesiology panel, where it files most

How often FDA has decided Ekom S.R.O.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ekom S.R.O. 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?

  • BTICompressor, Air, Portable2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 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.

  • K060781Medical Compressor, Models DK50 D and DMEkom S.R.O. · 20061cites it

What has FDA decided for it lately?

  • K091871DK50 DSEkom S.R.O. · 2009
  • K060781Medical Compressor, Models DK50 D and DMEkom S.R.O. · 2006

All 2 as Ekom S.R.O. →