510(k) · Cleared
ClearedMedrange Electrosurgical Expansion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medrange Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 23, 2012 as substantially equivalent to K081678 (Kls Martin GmbH + Co. KG, 2008) and 2 other predicates after a 99-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Oct 23, 2012
- Review
- 99 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K894762 (1989). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK894762 B100 Disposable HandpieceBeacon Laboratories, Inc. · 1989
- 3 generations backK963189 Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma…Erbe USA, Inc. · 1996
- 2 generations backK013348 Modification to: Erbe Apc Connector Hose and Probes, Models…Erbe USA, Inc. · 2001
- 1 generation backK081678 Conmed Beamer System C600Kls Martin GmbH + Co. KG · 2008
- This deviceK122092 Medrange Electrosurgical Expansion SystemMedrange Corporation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894762 | B100 Disposable Handpiece | Beacon Laboratories, Inc. | 1989 | — |
| −3 | K963189 | Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator… | Erbe USA, Inc. | 1996 | — |
| −2 | K013348 | Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158… | Erbe USA, Inc. | 2001 | — |
| −1 | K081678 | Conmed Beamer System C600 | Kls Martin GmbH + Co. KG | 2008 | — |
| 0 (this device) | K122092 | Medrange Electrosurgical Expansion System | Medrange Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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? (3)
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 |
|---|---|---|---|
| * | K081678 | Conmed Beamer System C600Summary page 1…Product Code: GEl Predicate Device Information Predicate DevicelI: Conted CE 600 5 10O(k) number: K(081678 Predicate Device2: ERBE VIO APC 2 510(k) number: K024047 Predicate De… | 2008 |
| * | K024047 | Erbe Vio Apc with AccessoriesSummary page 1…E 600 5 10O(k) number: K(081678 Predicate Device2: ERBE VIO APC 2 510(k) number: K024047 Predicate De vice 3: Force Argon 11 510(k) number: K(964636 Device Desc… | 2003 |
| * | K964636 | Force Argon II Argon Enhanced Electrosurgical SystemSummary page 1…APC 2 510(k) number: K024047 Predicate De vice 3: Force Argon 11 510(k) number: K(964636 Device Description The E ES 100 is an expa psion system for the el ectrosurgical unit (F SU). T he EE S 100 is no… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 6.8 years on median.
- None of the 12 ancestors has a recall.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
The EES 100 with Accessories is intended to deliver argon gas for argon plasma coagulation on tissue when used in conjunction with an Electrosurgical Generator and applicators or probes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122092: Medrange Electrosurgical Expansion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122092
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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