510(k) · Cleared
ClearedTBD
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 8, 1997 as substantially equivalent to K822572 (Valleylab, Inc., 1982) after a 20-day review. Its family tree reaches back 1 generation to 1982. 6 of the 10 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.
- Decided
- Jul 8, 1997
- Review
- 20 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K822572 (1982). 8 later devices descend from it, 1 citing it directly. 6 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK822572 Polyhesive Patient Return ElectrodeValleylab, Inc. · 1982
- This deviceK972273 TBDMegadyne Medical Products, Inc. · 1997
- Descendant · cites it directly · 7 of its ownK982826 MEGA 2000Megadyne Medical Products, Inc. · 1998 · Recalled (Class I)
- Descendant · 2 generations on · 6 of its ownK021077 Mega 2000 Soft Patient Return Electrode PadMegadyne Medical Products, Inc. · 2002 · Recalled (Class I)
- Descendant · 3 generations on · 5 of its ownK031285 Mega 2000 Soft Dual Cord Patient Return Electrode PadMegadyne Medical Products, Inc. · 2003 · Recalled (Class I)
- Descendant · 3 generations on · 4 of its ownK080741 Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · Recalled (Class I)
- Descendant · 4 generations on · 3 of its ownK133726 Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 2014 · Recalled (Class I)
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K982826MEGA 2000Megadyne Medical Products, Inc. · 1998 · cites it directly7descendants
- K021077Mega 2000 Soft Patient Return Electrode PadMegadyne Medical Products, Inc. · 2002 · 2 generations on6descendants
- K031285Mega 2000 Soft Dual Cord Patient Return Electrode PadMegadyne Medical Products, Inc. · 2003 · 3 generations on5descendants
- K080741Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · 3 generations on4descendants
- K133726Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 2014 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K822572 | Polyhesive Patient Return Electrode | Valleylab, Inc. | 1982 | — |
| 0 (this device) | K972273 | TBD | Megadyne Medical Products, Inc. | 1997 | — |
| +1 | K982826 | MEGA 2000 | Megadyne Medical Products, Inc. | 1998 | Class I |
| +2 | 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 |
| +3 | K080741 | Mega Soft Reusable Patient Return Electrode | Megadyne Medical Products, Inc. | 2008 | Class I |
| +4 | K133726 | Mega Soft Universal Patient Return Electrode | Megadyne Medical Products, Inc. | 2014 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 1 |
| 2002 | 1 | 1 |
| 2003 | 1 | 1 |
| 2008 | 1 | 1 |
| 2014 | 1 | 1 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 1 |
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 |
|---|---|---|---|
| * | K822572 | Polyhesive Patient Return ElectrodeSummary page 1…surgical, Patient Return Trade Name: Undetermined Classification (if known): 878.4400 Predicate Device: PolyHesive patient return electrode, manufactured by Valleylab (K822572) Device Description: The MegaDyne reusable patient return electrode is constructed of a layer of conductive material, laminated… | 1982 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982826 | MEGA 2000 Class I | 1998 | 7 |
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
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.
- K982826MEGA 2000Megadyne Medical Products, Inc. · 1998 · Cites it directly · ◆ in the 1998 descendants bar of FIG. 11 Class I recall
- K021077Mega 2000 Soft Patient Return Electrode PadMegadyne Medical Products, Inc. · 2002 · 2 generations on · ◆ in the 2002 descendants bar of FIG. 12 Class I recalls
- K031285Mega 2000 Soft Dual Cord Patient Return Electrode PadMegadyne Medical Products, Inc. · 2003 · 3 generations on · ◆ in the 2003 descendants bar of FIG. 12 Class I recalls
- K080741Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 13 Class I recalls
- K133726Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 15 Class I recalls
- K233644Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad -…Megadyne Medical Products, Inc. · 2024 · 5 generations on · ◆ in the 2024 descendants bar of FIG. 13 Class I recalls
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K982826 (Megadyne Medical Products, Inc., 1998) has gone furthest, with 7 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The MegaDyne reusable patient return electrode is to be used as a general purpose return electrode in any electrosurgical application in which a standard monopolar electrosurgical generator is used.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972273 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972273: TBD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972273
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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