510(k) · Cleared
ClearedO.R.Pro 300 Electrosurgical Generator Model 40001-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtrex, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 22, 1998 as substantially equivalent to K944602 (Valleylab, Inc., 1995) and 1 other predicate after a 38-day review. Its family tree reaches back 1 generation to 1995. 34 later devices descend from it.
- Decided
- Jun 22, 1998
- Review
- 38 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K944602 (1995). 2 ancestors in all. 34 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK944602 Valleylab Force FXValleylab, Inc. · 1995
- This deviceK981724 O.R.Pro 300 Electrosurgical Generator Model 40001-100Medtrex, Inc. · 1998
- Descendant · cites it directly · 33 of its ownK073057 Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue…Peak Surgical, Inc. · 2008
- Descendant · 2 generations on · 24 of its ownK082786 Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue…Peak Surgical, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 8 of its ownK093695 Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010
- Descendant · 2 generations on · 8 of its ownK083415 Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc. · 2009
- Descendant · 3 generations on · 7 of its ownK142410 Elliquence ElectrodesElliquence, LLC · 2015
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K073057Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model…Peak Surgical, Inc. · 2008 · cites it directly33descendants
- K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesPeak Surgical, Inc. · 2008 · 2 generations on24descendants
- K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010 · 3 generations on8descendants
- K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc. · 2009 · 2 generations on8descendants
- K142410Elliquence ElectrodesElliquence, LLC · 2015 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944602 | Valleylab Force FX | Valleylab, Inc. | 1995 | — |
| 0 (this device) | K981724 | O.R.Pro 300 Electrosurgical Generator Model 40001-100 | Medtrex, Inc. | 1998 | — |
| +1 | K073057 | Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection… | Peak Surgical, Inc. | 2008 | — |
| +2 | K082786 | Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection… | Peak Surgical, Inc. | 2008 | 1 |
| +3 | K093695 | Peak Plasmablade 3.OS Tissue Dissection Device | Peak Surgical, Inc. | 2010 | — |
| +2 | K083415 | Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection Device | Peak Surgical, Inc. | 2009 | — |
| +3 | K142410 | Elliquence Electrodes | Elliquence, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
Planning a device in GEI? 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? (2)
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 |
|---|---|---|---|
| * | K944602 | Valleylab Force FXSummary page 2…uivalent to the following two legally marketed electrosurgical generators: Valley Laboratories Inc. Boulder, Colorado 80301 Force FX™ Electrosurgical Generator 510(k) K944602, cleared 6/5/95 Aspen Surgical Systems Div of ConMed /Corporation 311 Broad Street Utica, NY 13501 ExcaliburPlus Electrosurg… | 1995 |
| * | K953007 | Excalibur Plus Electrosurgical UnitSummary page 2…tor 510(k) K944602, cleared 6/5/95 Aspen Surgical Systems Div of ConMed /Corporation 311 Broad Street Utica, NY 13501 ExcaliburPlus Electrosurgical Generator 510(k) K953007 Cleared 8/21/95 The O.R.Pro has been tested to all applicable requirements of 1 -R- — American National Electrosurgical Devices… | 1995 |
What descends from it? (34)
See all 341 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073057 | Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model… | 2008 | 33 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 O. R. Pro 300™ Electrosurgical Generator is a general purpose solid state generator
used to supply the RF signals to electrosurgical handpieces used on soft tissues where a
wide range of tissue types, patient conditions and load impedances are encountered.
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/K981724 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981724: O.R.Pro 300 Electrosurgical Generator Model 40001-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981724
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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