# Megadyne Medical Products, Inc.

- Location (FDA's records): Draper, UT
- FDA decisions: 50 (1990–2024): 50 510(k) clearances
- Product codes: GEI (32), JOS (2), LRO (2), KDD (2), FYD (2), FMJ (1), HGI (1), FMI (1), GCJ (1), JOH (1), MCY (1), JOL (1)
- 510(k) review time since 2016: median 102 days, against 115 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 23 (11 its own); citations of its devices by later devices: 40 (11 its own)
- Recalls linked to its devices: 31 (16 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Valleylab, Inc.: 4 (https://510kreport.com/company/valleylab)
- I.C Medical, Inc.: 2 (https://510kreport.com/company/i-c-medical)
- National Wire & Stamping, Inc.: 1 (https://510kreport.com/company/national-wire-stamping)
- Action Products, Inc.: 1 (https://510kreport.com/company/action-products)
- Leonhard Lang GmbH: 1 (https://510kreport.com/company/leonhard-lang)
- Linemaster Switch Corp.: 1 (https://510kreport.com/company/linemaster-switch)
- American Medical Products, Inc.: 1 (https://510kreport.com/company/american-medical-products)
- Utah Medical Products, Inc.: 1 (https://510kreport.com/company/utah-medical-products)

## Firms that cite its devices most
- Modern Medical Equipment Manufacturing Limited: 2 (https://510kreport.com/company/modern-medical-equipment-manufacturing)
- Covidien: 2 (https://510kreport.com/company/covidien)
- Utah Medical Products, Inc.: 2 (https://510kreport.com/company/utah-medical-products)
- Alesi Surgical, Ltd.: 2 (https://510kreport.com/company/alesi-surgical)
- Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company): 1 (https://510kreport.com/company/ethicon-endo-surgery-a-johnson-and-johnson)
- Porex Surgical, Inc.: 1 (https://510kreport.com/company/porex-surgical)
- Dannoritzer Medizintechnik GmbH & Co. KG: 1 (https://510kreport.com/company/dannoritzer-medizintechnik)
- Aaron Medical Industries: 1 (https://510kreport.com/company/aaron-medical-industries)

## Its most-cited devices
- K903302: Electrode, Electrosurgery (1990), cited by 4
- K913281: E-Z Clean Laparoscopic Electrode (1991), cited by 4
- K081791: E-Z Clean Electrosurgical Electrode (2008), cited by 4
- K965054: Pencil (1997), cited by 3
- K133726: Mega Soft Universal Patient Return Electrode (2014), cited by 3
- K141587: E-Z Clear Smoke Evacuation Electrosurgical Pencil;Clear Nozzle Extention, Ulpa Filter, Charcoal Filter, Adapter (2015), cited by 2

## Recent decisions
- K233644: Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848) (Jul 12, 2024)
- K213696: ETHICON Megadyne Electrosurgical Generator (Jan 21, 2022)
- K200250: Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor (Jun 26, 2020)
- K193145: Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch (Mar 24, 2020)
- K191328: Megadyne Foot Switch (Jul 26, 2019)
- K141587: E-Z Clear Smoke Evacuation Electrosurgical Pencil;Clear Nozzle Extention, Ulpa Filter, Charcoal Filter, Adapter (Feb 18, 2015)
- K133726: Mega Soft Universal Patient Return Electrode (Jan 24, 2014)
- K080741: Mega Soft Reusable Patient Return Electrode (Dec 16, 2008)

Source page: https://510kreport.com/company/megadyne-medical-products