Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Megadyne Medical Products, Inc. · Predicate Candidate Screening
50 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
183 days90th percentile
50clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233644 | Megadyne Patient Return Electrode Pad - Universal Dual (mode | Megadyne Medical Products, Inc. | 2024-07-12 | 242 | 3 |
| K213696 | ETHICON Megadyne Electrosurgical Generator | Megadyne Medical Products, Inc. | 2022-01-21 | 59 | 0 |
| K200250 | Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Tr | Megadyne Medical Products, Inc. | 2020-06-26 | 144 | 0 |
| K193145 | Ethicon Megadyne Electrosurgical Generator, Bipolar Footswit | Megadyne Medical Products, Inc. | 2020-03-24 | 132 | 0 |
| K191328 | Megadyne Foot Switch | Megadyne Medical Products, Inc. | 2019-07-26 | 71 | 0 |
| K141587 | E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZ | Megadyne Medical Products, Inc. | 2015-02-18 | 250 | 0 |
| K133726 | MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE | Megadyne Medical Products, Inc. | 2014-01-24 | 49 | 5 |
| K080741 | MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE | Megadyne Medical Products, Inc. | 2008-12-16 | 274 | 3 |
| K081791 | E-Z CLEAN ELECTROSURGICAL ELECTRODE | Megadyne Medical Products, Inc. | 2008-10-21 | 118 | 1 |
| K072559 | SUCTION COAGULATOR | Megadyne Medical Products, Inc. | 2007-10-05 | 24 | 2 |
| K050579 | MEGA POWER ELECTROSURGICAL GENERATOR | Megadyne Medical Products, Inc. | 2005-03-24 | 17 | 1 |
| K050102 | E-Z PEN, REUSEABLE HANDSWITCHING PENCIL | Megadyne Medical Products, Inc. | 2005-02-01 | 14 | 0 |
| K040699 | LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS) | Megadyne Medical Products, Inc. | 2004-06-04 | 79 | 0 |
| K031285 | MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD | Megadyne Medical Products, Inc. | 2003-05-19 | 26 | 2 |
| K021077 | MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD | Megadyne Medical Products, Inc. | 2002-04-17 | 14 | 2 |
| K982826 | MEGA 2000 | Megadyne Medical Products, Inc. | 1998-11-06 | 87 | 1 |
| K973346 | UNCOATED ELECTROSURGICAL ELECTRODE | Megadyne Medical Products, Inc. | 1997-11-07 | 63 | 0 |
| K972273 | TBD | Megadyne Medical Products, Inc. | 1997-07-08 | 20 | 0 |
| K965054 | PENCIL | Megadyne Medical Products, Inc. | 1997-01-24 | 37 | 8 |
| K953479 | BIPOLAR FORCEPS | Megadyne Medical Products, Inc. | 1995-10-12 | 80 | 0 |
| K946237 | ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSOR | Megadyne Medical Products, Inc. | 1995-06-07 | 167 | 0 |
| K951035 | BIPOLAR FORCEPS | Megadyne Medical Products, Inc. | 1995-04-07 | 32 | 0 |
| K943055 | ELECTROSURGICAL CUTTING AND COAGULATING DEVICE AND ACCESSORI | Megadyne Medical Products, Inc. | 1994-12-21 | 177 | 2 |
| K945898 | ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSOR | Megadyne Medical Products, Inc. | 1994-12-13 | 11 | 0 |
| K942306 | IRRIGATION/ASPIRATION INSTRUMENT | Megadyne Medical Products, Inc. | 1994-09-23 | 133 | 0 |
| K942489 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE | Megadyne Medical Products, Inc. | 1994-07-25 | 61 | 0 |
| K925478 | ELECTROSURGICAL ELECTRODE | Megadyne Medical Products, Inc. | 1994-06-27 | 606 | 0 |
| K933085 | GOODMAN BANDAGE | Megadyne Medical Products, Inc. | 1993-12-23 | 183 | 0 |
| K932102 | ELECTROSURGICAL ELECTRODE | Megadyne Medical Products, Inc. | 1993-09-23 | 143 | 0 |
| K926306 | FOOT CONTROL PENCIL | Megadyne Medical Products, Inc. | 1993-02-05 | 52 | 0 |
| K922002 | SUCTION IRRIGATION CAUTERY PROBE | Megadyne Medical Products, Inc. | 1992-09-02 | 126 | 0 |
| K913141 | MEGA MYELOGRAM KIT | Megadyne Medical Products, Inc. | 1991-10-17 | 93 | 0 |
| K912597 | ELECTROSURGICAL ELECTRODE | Megadyne Medical Products, Inc. | 1991-09-06 | 88 | 0 |
| K913473 | E-Z CLEAN ELECTRODE | Megadyne Medical Products, Inc. | 1991-09-06 | 32 | 0 |
| K912337 | ELECTROSURGICAL CUT & COAGULATION DEVICE & ACCESS | Megadyne Medical Products, Inc. | 1991-08-16 | 84 | 0 |
| K913281 | E-Z CLEAN LAPAROSCOPIC ELECTRODE | Megadyne Medical Products, Inc. | 1991-08-16 | 23 | 1 |
| K911586 | GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC) | Megadyne Medical Products, Inc. | 1991-07-02 | 84 | 0 |
| K910089 | MEGA LUMBAR PUNCTURE KIT | Megadyne Medical Products, Inc. | 1991-06-20 | 162 | 0 |
| K910963 | THOROCENTESIS KIT | Megadyne Medical Products, Inc. | 1991-06-20 | 106 | 0 |
| K905060 | ELECTRODE EXTENDER | Megadyne Medical Products, Inc. | 1991-04-12 | 155 | 0 |
| K910362 | TRACHEOSTOMY CARE KIT | Megadyne Medical Products, Inc. | 1991-04-08 | 69 | 0 |
| K910363 | MEGA DRESSING CHANGE KIT | Megadyne Medical Products, Inc. | 1991-03-28 | 58 | 0 |
| K910365 | WOUND CLOSURE KIT | Megadyne Medical Products, Inc. | 1991-03-28 | 58 | 0 |
| K910366 | MEGA GENERAL PURPOSE INSTRUMENT KIT | Megadyne Medical Products, Inc. | 1991-03-28 | 58 | 0 |
| K910369 | INCISION AND DRAINAGE KIT | Megadyne Medical Products, Inc. | 1991-03-28 | 58 | 0 |
| K910361 | SUTURE REMOVAL KIT | Megadyne Medical Products, Inc. | 1991-03-27 | 57 | 0 |
| K910368 | MEGA LACERATION KIT | Megadyne Medical Products, Inc. | 1991-03-18 | 48 | 0 |
| K904808 | ELECTROSURGICAL PENCIL | Megadyne Medical Products, Inc. | 1991-01-04 | 72 | 0 |
| K903302 | ELECTRODE, ELECTROSURGERY | Megadyne Medical Products, Inc. | 1990-10-02 | 70 | 0 |
| K903006 | ELECTROSURGICAL BIPOLAR FORCEPS | Megadyne Medical Products, Inc. | 1990-09-20 | 71 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda