510(k) Report

FDA applicant

Medical Devices, Inc.

St. Paul, MN49 decisions1977–20016 recalls

FDA records 49 decisions for Medical Devices, Inc. (St. Paul, MN) from 1977 to 2001: 49 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) and GXY (Electrode, Cutaneous). 6 recalls are linked to its devices, 1 Class I.

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 Medical Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

5in 2018

2014: 1, 1 Class I2018: 5
2007high 5 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Medical Devices, 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?

  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief16decisions
  • GXYElectrode, Cutaneous7decisions
  • KNXCollector, Urine, (And Accessories) For Indwelling Catheter4decisions
  • IPFStimulator, Muscle, Powered4decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories3decisions
  • CAWGenerator, Oxygen, Portable2decisions

Also: KOD (2), LIH (1), FWF (1), EYN (1), HRX (1), MKJ (1).

Who builds on its devices?

Later devices cite its devices 11 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.

  • K895473DSX (TM), Digital SX, Quantum DSX, Model 4700SMedical Devices, Inc. · 19894cite it
  • K935132Home Microcurrent HMCMedical Devices, Inc. · 19942cite it
  • K923914IF-II (TM), Model 7200Medical Devices, Inc. · 19922cite it
  • K002280Pad Pro Pediatric Electrode, Model Pad Pro 2602Medical Devices, Inc. · 20011cites it
  • K872657Ultrapac II SX Plus (TM)Medical Devices, Inc. · 19871cites it
  • K881082GV 11 (TM), Model 9700Medical Devices, Inc. · 19881cites it

What has FDA decided for it lately?

  • K002280Pad Pro Pediatric Electrode, Model Pad Pro 2602Medical Devices, Inc. · 20011 Class I recall
  • K930084Micro-ArthroscopeMedical Devices, Inc. · 1995
  • K940012Smartbrace ElectrodeMedical Devices, Inc. · 1994
  • K943126ElectroflexMedical Devices, Inc. · 1994
  • K935132Home Microcurrent HMCMedical Devices, Inc. · 1994
  • K934619FlexmateMedical Devices, Inc. · 1994
  • K924897Xenon Endoscopic Illuminator, Model Xei-300Medical Devices, Inc. · 1993
  • K930053Video Camera W/ Electronic Shutter Model Vce-10Medical Devices, Inc. · 1993

All 49 as Medical Devices, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K002280MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z…Feb 23, 2018Class II
  • K002280MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog…Feb 23, 2018Class II
  • K002280MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector…Feb 23, 2018Class II
  • K002280MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog…Feb 23, 2018Class II
  • K002280MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog…Feb 23, 2018Class II
  • K002280MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY ---…Nov 6, 2014Class I