510(k) Report

FDA applicant

Medcare Flaga

Reykjavik, IS4 decisions2003–20040 recalls

FDA records 4 decisions for Medcare Flaga (Reykjavik, IS) from 2003 to 2004: 4 510(k) clearances. All are in product code MNR (Ventilatory Effort Recorder). Its devices cite 9 predicates, 2 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 Medcare Flaga’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medcare Flaga since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medcare Flaga 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?

  • MNRVentilatory Effort Recorder4decisions

Whose devices does it build on?

Its devices cite 9 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 2 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.

  • K024322Embla N7000Medcare Flaga · 20035cite it
  • K041904Compass F10 SystemMedcare Flaga · 20044cite it
  • K043132Universal XacttraceMedcare Flaga · 20042cite it
  • K041724Compass M10 SystemMedcare Flaga · 20042cite it

What has FDA decided for it lately?

  • K043132Universal XacttraceMedcare Flaga · 2004
  • K041724Compass M10 SystemMedcare Flaga · 2004
  • K041904Compass F10 SystemMedcare Flaga · 2004
  • K024322Embla N7000Medcare Flaga · 2003

All 4 as Medcare Flaga →

Other applicant names beginning “Medcare”

FDA records each applicant name separately; these may or may not be the same firm.

Medcare Products 20Medcare Custom Packaging, Inc. 11Medcare Medical Group, Inc. 8Medcare Disp Products, Inc. 6Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi 1Medcare Manufacturing, Inc. 1