510(k) Report

FDA applicant

Ams Medical, Inc.

Minneapolis, MN1 decision1985–19850 recalls

FDA records 1 decision for Ams Medical, Inc. (Minneapolis, MN) in 1985: 1 510(k) clearance. All are in product code DXH (Transmitters And Receivers…). 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 Ams Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ams Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ams Medical, Inc.’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?

  • DXHTransmitters And Receivers, Electrocardiograph, Telephone1decision

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.

  • K844391Novacor's R-Test 60 & R-Test 160 Ecg RecordersAms Medical, Inc. · 19851cites it

What has FDA decided for it lately?

  • K844391Novacor's R-Test 60 & R-Test 160 Ecg RecordersAms Medical, Inc. · 1985

The one decision as Ams Medical, Inc. →