510(k) Report

FDA applicant

Eureka AB

Stockholm, Sweden, SE1 decision1988–19880 recalls

FDA records 1 decision for Eureka AB (Stockholm, Sweden, SE) in 1988: 1 510(k) clearance. All are in product code JOM (Plethysmograph, Photoelectric, Pneumatic Or…). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Eureka AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Eureka AB 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?

  • JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic1decision

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.

  • K882547VaritestEureka AB · 19881cites it

What has FDA decided for it lately?

The one decision as Eureka AB →

Other applicant names beginning “Eureka”

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

Eureka X-Ray Tube Corp. 2Eureka Optics, Inc. 1Eureka Laboratories, Inc. 1