510(k) Report

FDA applicant

Lamont Medical, Inc.

Stoughton, WI2 decisions1999–20040 recalls

FDA records 2 decisions for Lamont Medical, Inc. (Stoughton, WI) from 1999 to 2004: 2 510(k) clearances. All are in product code OLV (Standard Polysomnograph With…). Its devices cite 2 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, neurology panel, where it files most

How often FDA has decided Lamont Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Lamont Medical, Inc.’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?

  • OLVStandard Polysomnograph With Electroencephalograph2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K990522Waratah Digital Eeg and Sleep Acquisition Devices with, or Without, Pulse Oximetry,Cardinal Digital Eeg and…Lamont Medical, Inc. · 19993cite it

What has FDA decided for it lately?

  • K042364Panbus Digital Eeg & Sleep Acquisition DevicesLamont Medical, Inc. · 2004
  • K990522Waratah Digital Eeg and Sleep Acquisition Devices with, or Without, Pulse Oximetry,Cardinal Digital Eeg and…Lamont Medical, Inc. · 1999

All 2 as Lamont Medical, Inc. →