510(k) · Cleared
ClearedMedrange Electrosurgical Generator
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 Nov 22, 2010 as substantially equivalent to K953007 (Aspen Laboratories, Inc., 1995) and 1 other predicate after a 117-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Nov 22, 2010
- Review
- 117 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. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK944602 Valleylab Force FXValleylab, Inc. · 1995
- This deviceK102114 Medrange Electrosurgical GeneratorMedrange Corporation · 2010
- Descendant · cites it directly · 1 of its ownK201224 Electrosurgical Generator and AccessoriesMedrange · 2020
- Descendant · 2 generations on · 0 of its ownK253777 Ascblue (8010)Ascblue Corporation · 2026
Most influential descendants
Showing 2 of 2 · See allView 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) | K102114 | Medrange Electrosurgical Generator | Medrange Corporation | 2010 | — |
| +1 | K201224 | Electrosurgical Generator and Accessories | Medrange | 2020 | — |
| +2 | K253777 | Ascblue (8010) | Ascblue Corporation | 2026 | — |
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 |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K953007 | Excalibur Plus Electrosurgical UnitSummary page 1…REDICATE DEVICE INFORMATION [21CFR 807.92(a)(3)] Predicate Devicel: ConMed Excalibur Plus PC Aspen Laboratories Inc. 510(k) number: K953007 Predicate Device2: Valley lab FXTM Valleylab, a Division of Tyco Healthcare LP 510(k) numb… | 1995 |
| * | K944602 | Valleylab Force FXSummary page 1…510(k) number: K953007 Predicate Device2: Valley lab FXTM Valleylab, a Division of Tyco Healthcare LP 510(k) number: K944602 DEVICE DESCRIPTION [21CFR 807.92(a)(4)) Medrange MB 8010 ESU is an electrosurgical generator with monopolar pure… | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201224 | Electrosurgical Generator and Accessories | 2020 | 1 |
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. 2010, 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?
MB8010 Electrosurgical generator is indicated for monopolar cutting and coagulation and bipolar coagulation in surgical procedures and is intended to be used with monopolar handpieces and ground pad or bipolar handpieces and footswitches.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102114 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102114: Medrange Electrosurgical Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102114
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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