510(k) · Cleared
ClearedBergen Model 500 Electrosurgery Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bergen Mfg. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 27, 1997 as substantially equivalent to K945861 (Bergen Mfg., 1995) and 1 other predicate after a 69-day review. Its family tree reaches back 1 generation to 1995. 978 later devices descend from it.
- Decided
- Aug 27, 1997
- Review
- 69 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K945861 (1995). 2 ancestors in all. 978 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK945861 Bergen 710 EsuBergen Mfg. · 1995
- This deviceK972299 Bergen Model 500 Electrosurgery GeneratorBergen Mfg. · 1997
- Descendant · cites it directly · 977 of its ownK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- Descendant · 2 generations on · 973 of its ownK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- Descendant · 2 generations on · 714 of its ownK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- Descendant · 3 generations on · 705 of its ownK022266 Aurora SRSyneron Medical, Ltd. · 2002
- Descendant · 3 generations on · 695 of its ownK020339 Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas…Dornier Medtech America, Inc. · 2002
Showing 5 of 978 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 978 · See all- K974521Vnus Closure SystemVnus Medical Technologies, Inc. · 1998 · cites it directly977descendants
- K982816Vnus Closure SystemVnus Medical Technologies, Inc. · 1999 · 2 generations on973descendants
- K012398Diomed 15 Diode LaserDiomed, Ltd. · 2002 · 2 generations on714descendants
- K022266Aurora SRSyneron Medical, Ltd. · 2002 · 3 generations on705descendants
- K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…Dornier Medtech America, Inc. · 2002 · 3 generations on695descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945861 | Bergen 710 Esu | Bergen Mfg. | 1995 | — |
| 0 (this device) | K972299 | Bergen Model 500 Electrosurgery Generator | Bergen Mfg. | 1997 | — |
| +1 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| +2 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| +2 | K012398 | Diomed 15 Diode Laser | Diomed, Ltd. | 2002 | — |
| +3 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| +3 | K020339 | Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D… | Dornier Medtech America, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 9 | 0 |
| 2004 | 6 | 0 |
| 2005 | 12 | 0 |
| 2006 | 8 | 0 |
| 2007 | 12 | 0 |
| 2008 | 26 | 0 |
| 2009 | 20 | 0 |
| 2010 | 27 | 0 |
| 2011 | 20 | 0 |
| 2012 | 19 | 0 |
| 2013 | 26 | 0 |
| 2014 | 37 | 0 |
| 2015 | 36 | 0 |
| 2016 | 50 | 0 |
| 2017 | 52 | 0 |
| 2018 | 48 | 0 |
| 2019 | 35 | 0 |
| 2020 | 47 | 0 |
| 2021 | 47 | 0 |
| 2022 | 70 | 0 |
| 2023 | 66 | 0 |
| 2024 | 92 | 0 |
| 2025 | 131 | 0 |
| 2026 | 76 | 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 |
|---|---|---|---|
| * | K945861 | Bergen 710 EsuSummary page 1…0-50. Outputs of both generators are independently controlled and RF isolated from cach other. The monopolar electrosurgery generator is similar to the Bergen Model 710 K945861 but without digital displays and calibrated to higher power levels. The bipolar generator is similar to the Bergen Model 610 K964… | 1995 |
| * | K964736 | Bergen 610 Bipolar CoagulatorSummary page 1…r is similar to the Bergen Model 710 K945861 but without digital displays and calibrated to higher power levels. The bipolar generator is similar to the Bergen Model 610 K964736 but without digital power setting display and current monitor. Each generator handswitch system is powered by independent low vo… | 1997 |
What descends from it? (978)
See all 9781 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974521 | Vnus Closure System | 1998 | 977 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K974521 (Vnus Medical Technologies, Inc., 1998) has gone furthest, with 977 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 Bergen Model 500 Generator is a general purpose solid state generator to supply the RF signal to electrosurgical handpieces used on soft body 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/K972299 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972299: Bergen Model 500 Electrosurgery Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972299
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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