510(k) · Cleared
Recalled · Class I · 2023Megadyne 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)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Megadyne Medical Products, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 12, 2024 as substantially equivalent to K133726 (Megadyne Medical Products, Inc., 2014) after a 242-day review. Its family tree reaches back 7 generations to 1982. 6 of the 18 devices in its family, counting itself, have a Class I recall. It has been recalled 3 times, including 3 Class I recalls.
- Decided
- Jul 12, 2024
- Review
- 242 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 3 (3 Class I)
- Predicates
- 1
Its longest line of descent runs back 7 generations to K822572 (1982). 17 ancestors in all, the oldest K801694 (1980). No later device cites it as a predicate yet. 6 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK822572 Polyhesive Patient Return ElectrodeValleylab, Inc. · 1982
- 6 generations backK972273 TBDMegadyne Medical Products, Inc. · 1997
- 5 generations backK982826 MEGA 2000Megadyne Medical Products, Inc. · 1998 · Recalled (Class I)
- 4 generations backK021077 Mega 2000 Soft Patient Return Electrode PadMegadyne Medical Products, Inc. · 2002 · Recalled (Class I)
- 3 generations backK031285 Mega 2000 Soft Dual Cord Patient Return Electrode PadMegadyne Medical Products, Inc. · 2003 · Recalled (Class I)
- 2 generations backK080741 Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · Recalled (Class I)
- 1 generation backK133726 Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 2014 · Recalled (Class I)
- This deviceK233644 Megadyne Patient Return Electrode Pad - Universal Dual (model 0846)…Megadyne Medical Products, Inc. · 2024
Class I recalls in this family
- K133726 Mega Soft Universal Patient Return Electrodedirect predicate · 2014
- K080741 Mega Soft Reusable Patient Return Electrode2 generations back · 2008
- K031285 Mega 2000 Soft Dual Cord Patient Return…3 generations back · 2003
- K021077 Mega 2000 Soft Patient Return Electrode Pad3 generations back · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K822572 | Polyhesive Patient Return Electrode | Valleylab, Inc. | 1982 | — |
| −6 | K972273 | TBD | Megadyne Medical Products, Inc. | 1997 | — |
| −5 | K982826 | MEGA 2000 | Megadyne Medical Products, Inc. | 1998 | Class I |
| −4 | K021077 | Mega 2000 Soft Patient Return Electrode Pad | Megadyne Medical Products, Inc. | 2002 | Class I |
| −3 | K031285 | Mega 2000 Soft Dual Cord Patient Return Electrode Pad | Megadyne Medical Products, Inc. | 2003 | Class I |
| −2 | K080741 | Mega Soft Reusable Patient Return Electrode | Megadyne Medical Products, Inc. | 2008 | Class I |
| −1 | K133726 | Mega Soft Universal Patient Return Electrode | Megadyne Medical Products, Inc. | 2014 | Class I |
| 0 (this device) | K233644 | Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne… | Megadyne Medical Products, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
6 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133726 | Mega Soft Universal Patient Return ElectrodeSummary page 5…DEVICES Predicate Device 510(k) Number Predicate Device Name Model (Clearance Date) K133726 Mega Soft Universal Patient… | 2014 |
| † | K031285 | Mega 2000 Soft Dual Cord Patient Return Electrode Pad | 2003 |
| † | K080741 | Mega Soft Reusable Patient Return Electrode | 2008 |
| † | K183148 | OKLand Patient Return Electrode Pad | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 8, 2023 | Class I | Z-0598-2024 | Under Investigation by firm | Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital… |
| Dec 8, 2023 | Class I | Z-0599-2024 | Under Investigation by firm | Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital… |
| Dec 8, 2023 | Class I | Z-0600-2024 | Under Investigation by firm | Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K133726Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 2014 · Direct predicate · ◆ on the line of descent in FIG. 15 Class I recalls
- K080741Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
- K031285Mega 2000 Soft Dual Cord Patient Return Electrode PadMegadyne Medical Products, Inc. · 2003 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K021077Mega 2000 Soft Patient Return Electrode PadMegadyne Medical Products, Inc. · 2002 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K982826MEGA 2000Megadyne Medical Products, Inc. · 1998 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 42 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- 5 of the 17 ancestors have a recall of any class; 5 have a Class I recall.
- 2 other devices also cite its predicate K133726.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
This device is designed to be used whenever monopolar electrosurgery is indicated. The intended use of this device is to conduct monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units (ESU), or generators.
Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators. The device is not intended for RF ablation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233644 · printed Nov 3, 2026
Cite this page
510(k) Report. “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).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K233644
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026