510(k) Report

FDA applicant

Megadyne Medical Products, Inc.

Draper, UT50 decisions1990–202431 recalls

FDA records 50 decisions for Megadyne Medical Products, Inc. (Draper, UT) from 1990 to 2024: 50 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and JOS (Electrode, Electrosurgical). Since 2016 its 510(k)s took a median of 102 days from receipt to decision, against 115 for FDA’s reviews in the same codes and years. Its devices cite 23 predicates, 11 of them its own earlier devices. 31 recalls are linked to its devices, 16 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2024

2007: 12008: 22014: 12015: 12019: 12020: 22022: 12024: 1
2007high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

4in 2024

2009: 12013: 12014: 12018: 12023: 13, 12 Class I2024: 4, 4 Class I
2007high 13 (2023) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Megadyne Medical Products, 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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories32decisions
  • JOSElectrode, Electrosurgical2decisions
  • LROGeneral Surgery Tray2decisions
  • KDDKit, Surgical Instrument, Disposable2decisions
  • FYDApparatus, Exhaust, Surgical2decisions
  • FMJManometer, Spinal-Fluid1decision

Also: HGI (1), FMI (1), GCJ (1), JOH (1), MCY (1), JOL (1).

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 102 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 115 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 23 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 40 times; 11 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.

  • K903302Electrode, ElectrosurgeryMegadyne Medical Products, Inc. · 19904cite it
  • K913281E-Z Clean Laparoscopic ElectrodeMegadyne Medical Products, Inc. · 19914cite it
  • K081791E-Z Clean Electrosurgical ElectrodeMegadyne Medical Products, Inc. · 20084cite it
  • K965054PencilMegadyne Medical Products, Inc. · 19973cite it
  • K133726Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 20143cite it
  • K141587E-Z Clear Smoke Evacuation Electrosurgical Pencil;Clear Nozzle Extention, Ulpa Filter, Charcoal Filter…Megadyne Medical Products, Inc. · 20152cite it

What has FDA decided for it lately?

  • K233644Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad -…Megadyne Medical Products, Inc. · 20243 Class I recalls
  • K213696ETHICON Megadyne Electrosurgical GeneratorMegadyne Medical Products, Inc. · 2022
  • K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m…Megadyne Medical Products, Inc. · 2020
  • K193145Ethicon Megadyne Electrosurgical Generator, Bipolar FootswitchMegadyne Medical Products, Inc. · 2020
  • K191328Megadyne Foot SwitchMegadyne Medical Products, Inc. · 2019
  • K141587E-Z Clear Smoke Evacuation Electrosurgical Pencil;Clear Nozzle Extention, Ulpa Filter, Charcoal Filter…Megadyne Medical Products, Inc. · 2015
  • K133726Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 20145 Class I recalls
  • K080741Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 20083 Class I recalls

All 50 as Megadyne Medical Products, Inc. →

What has been recalled?

31 recalls linked to its devices; the latest:

  • K031285Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name…Jun 17, 2024Class I
  • K021077Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name…Jun 17, 2024Class I
  • K080741Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA…Jun 17, 2024Class I
  • K080741MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode…May 8, 2024Class I
  • K233644Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable…Dec 8, 2023Class I
  • K133726Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable…Dec 8, 2023Class I