510(k) Report

FDA applicant

Bio-Research Associates, Inc.

Milwaukee, WI10 decisions1982–20130 recalls

FDA records 10 decisions for Bio-Research Associates, Inc. (Milwaukee, WI) from 1982 to 2013: 10 510(k) clearances. Most are in product codes KZM (Device, Muscle Monitoring) and GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). Its devices cite 4 predicates, 3 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, physical medicine panel, where it files most

How often FDA has decided Bio-Research Associates, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2009: 12013: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bio-Research Associates, 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?

  • KZMDevice, Muscle Monitoring5decisions
  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief2decisions
  • KNTTubes, Gastrointestinal (And Accessories)1decision
  • NFSDevice, Jaw Tracking, For Monitoring Jaw Positions1decision
  • DQDStethoscope, Electronic1decision

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K082927Bioemg IiiBio-Research Associates, Inc. · 20091cites it
  • K9917563 Channel Knee Electronic Amplified StethoscopeBio-Research Associates, Inc. · 19991cites it
  • K844618Bio-TensBio-Research Associates, Inc. · 19851cites it
  • K003176Bioemg II and BiojvaBio-Research Associates, Inc. · 20011cites it

What has FDA decided for it lately?

  • K130158M-SCANBio-Research Associates, Inc. · 2013
  • K082927Bioemg IiiBio-Research Associates, Inc. · 2009
  • K061799Quadratens, Model QT-42Bio-Research Associates, Inc. · 2006
  • K003176Bioemg II and BiojvaBio-Research Associates, Inc. · 2001
  • K9917563 Channel Knee Electronic Amplified StethoscopeBio-Research Associates, Inc. · 1999
  • K981563Biopak Measurement SystemBio-Research Associates, Inc. · 1998
  • K952218JT-3 ElectrognathographBio-Research Associates, Inc. · 1995
  • K873947Bio-Emg Model 800Bio-Research Associates, Inc. · 1988

All 10 as Bio-Research Associates, Inc. →