510(k) Report

FDA applicant

Medical Research Laboratories, Inc.

Buffalo Grove, IL19 decisions1981–200213 recalls

FDA records 19 decisions for Medical Research Laboratories, Inc. (Buffalo Grove, IL) from 1981 to 2002: 19 510(k) clearances. Most are in product codes MKJ (Automated External Defibrillators (Non-Wearable)) and LDD (Dc-Defibrillator, Low-Energy, (Including…). 13 recalls are 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 Medical Research Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Research Laboratories, Inc. since 2007.

Recalls per year

1in 2010

2007: 22008: 32009: 22010: 1
2007high 3 (2008) · low 0 (2011)2026

Class I Class II/III not classified

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

Planning a device like Medical Research Laboratories, 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?

  • MKJAutomated External Defibrillators (Non-Wearable)7decisions
  • LDDDc-Defibrillator, Low-Energy, (Including Paddles)5decisions
  • DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)2decisions
  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase1decision
  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief1decision
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive1decision

Also: DQA (1).

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K930548DPD DefibrillatorMedical Research Laboratories, Inc. · 19931cites it
  • K952085DPD DefibrillatorMedical Research Laboratories, Inc. · 19951cites it
  • K012766Portable Intensive Care UnitMedical Research Laboratories, Inc. · 20021cites it

What has FDA decided for it lately?

  • K021168Jump Start, Model 970300Medical Research Laboratories, Inc. · 20027 recalls
  • K012766Portable Intensive Care UnitMedical Research Laboratories, Inc. · 2002
  • K012030Portable Intensive Care UnitMedical Research Laboratories, Inc. · 2001
  • K010207Portable Instensive Care UnitMedical Research Laboratories, Inc. · 2001
  • K002232AedefibrillatorMedical Research Laboratories, Inc. · 20003 recalls
  • K000712Portable Intensive Care Unit, Model PicMedical Research Laboratories, Inc. · 2000
  • K983307Modification to Portable Intensive Care UnitMedical Research Laboratories, Inc. · 1998
  • K974034Portable Intensive Care UnitMedical Research Laboratories, Inc. · 19983 recalls

All 19 as Medical Research Laboratories, Inc. →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K974034Welch Allyn PIC 50 Portable Intensive Care System. Model 971081 series. Designed for use…Sep 17, 2010
  • K021168Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED…Apr 24, 2009
  • K021168Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED…Feb 26, 2009
  • K021168Welch Allyn AED 10 Automated External DefibrillatorDec 15, 2008
  • K021168Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED…Dec 15, 2008
  • K021168Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED…Dec 15, 2008