Megadyne Medical Products, Inc.: FDA filings under this applicant name
FDA lists 50 510(k) clearances under the applicant name “Megadyne Medical Products, Inc.” (first 1990, latest 2024), across 15 product codes in 4 review panels. Median 510(k) review time under this name: 71 days. Since 2017 the median was 132 days, against 114 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 49 |
| 2015 | 1 | 250 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 71 |
| 2020 | 2 | 138 |
| 2021 | 0 | — |
| 2022 | 1 | 59 |
| 2023 | 0 | — |
| 2024 | 1 | 242 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Megadyne Medical Products, Inc. took a median 132 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 32 | 32 |
| FYD | Apparatus, Exhaust, Surgical | 2 | 2 |
| JOS | Electrode, Electrosurgical | 2 | 2 |
| KDD | Kit, Surgical Instrument, Disposable | 2 | 2 |
| LRO | General Surgery Tray | 2 | 2 |
| BYY | Tube, Aspirating, Flexible, Connecting | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FMJ | Manometer, Spinal-Fluid | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 1 | 1 |
Plus 5 more product codes.
Review panels
Most recent Megadyne Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| 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) | GEI | 2024-07-12 | 242 |
| K213696 | ETHICON Megadyne Electrosurgical Generator | GEI | 2022-01-21 | 59 |
| K200250 | Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor | FYD | 2020-06-26 | 144 |
| K193145 | Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch | GEI | 2020-03-24 | 132 |
| K191328 | Megadyne Foot Switch | FYD | 2019-07-26 | 71 |
| K141587 | E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER | GEI | 2015-02-18 | 250 |
| K133726 | MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE | GEI | 2014-01-24 | 49 |
| K080741 | MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE | GEI | 2008-12-16 | 274 |
| K081791 | E-Z CLEAN ELECTROSURGICAL ELECTRODE | GEI | 2008-10-21 | 118 |
| K072559 | SUCTION COAGULATOR | GEI | 2007-10-05 | 24 |
40 earlier clearances. See the full list in Caduvo.
Recalls
31 product recalls in 11 recall events; 17 initiated in the last five years. Most recent: 2024-06-17.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Megadyne Medical Products, Inc.?
FDA lists 50 510(k) clearances under the applicant name “Megadyne Medical Products, Inc.” (first 1990, latest 2024), across 15 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Megadyne Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Megadyne Medical Products, Inc. is 71 days. Since 2017: 132 days, versus 114 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Megadyne Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 32); FYD (Apparatus, Exhaust, Surgical, 2); JOS (Electrode, Electrosurgical, 2).
Next steps
- See all 50 Megadyne Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Megadyne Medical Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.