510(k) Report

FDA applicant

New England Medical Instruments, Inc.

Lexington, MA3 decisions1991–19960 recalls

FDA records 3 decisions for New England Medical Instruments, Inc. (Lexington, MA) from 1991 to 1996: 3 510(k) clearances. Most are in product codes OMB (Automatic Event Detection Software For…) and GWQ (Full-Montage Standard Electroencephalograph). 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 New England Medical Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for New England Medical Instruments, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — New England Medical Instruments, Inc. 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?

  • OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph2decisions
  • GWQFull-Montage Standard Electroencephalograph1decision

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.

  • K910771Digitrace (TM) Home Monit Comp/Elb (TM) Eeg Lunch BXNew England Medical Instruments, Inc. · 19911cites it

What has FDA decided for it lately?

  • K955787Digitrace Home Video SystemNew England Medical Instruments, Inc. · 1996
  • K910771Digitrace (TM) Home Monit Comp/Elb (TM) Eeg Lunch BXNew England Medical Instruments, Inc. · 1991
  • K910279Mcseer/Micro Controller SLD ST Eeg Event RecorderNew England Medical Instruments, Inc. · 1991

All 3 as New England Medical Instruments, Inc. →