510(k) · Cleared
ClearedVapr Vue Generator, Vapr 3 Electrosurgical System, Vapr II Electrosurgical System Coolpluse 90 and Coolpluse 90 with Han
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 27, 2012 as substantially equivalent to K041810 (Stryker Endoscopy, 2004) after an 88-day review. Its family tree reaches back 7 generations to 2001. 7 later devices descend from it.
- Decided
- Feb 27, 2012
- Review
- 88 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K011083 (2001). 17 ancestors in all, the oldest K974022 (1998). 7 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 6 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 5 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 4 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 3 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 2 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- 1 generation backK041810 Serfas Energy SystemStryker Endoscopy · 2004 · Recalled
- This deviceK113545 Vapr Vue Generator, Vapr 3 Electrosurgical System, Vapr II…Depuy Mitek, A Johnson & Johnson Company · 2012
- Descendant · cites it directly · 3 of its ownK152777 Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK161558 Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and…Bovie Medical Corporation · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK231126 Eblator DeviceE Surgical, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK251899 E BlatorNew Deantronics Taiwan, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK173740 Reprocessed DePuy Mitek Ablation WandRenovo, Inc. · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · cites it directly3descendants
- K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…Bovie Medical Corporation · 2016 · 2 generations on2descendants
- K231126Eblator DeviceE Surgical, LLC · 2023 · 2 generations on1descendant
- K251899E BlatorNew Deantronics Taiwan, Ltd. · 2025 · 3 generations on0descendants
- K173740Reprocessed DePuy Mitek Ablation WandRenovo, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −6 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −5 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −4 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −3 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −2 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| −1 | K041810 | Serfas Energy System | Stryker Endoscopy | 2004 | 3 |
| 0 (this device) | K113545 | Vapr Vue Generator, Vapr 3 Electrosurgical System, Vapr II Electrosurgical… | Depuy Mitek, A Johnson & Johnson Company | 2012 | — |
| +1 | K152777 | Bovie Disposable Bipolar Ablator | Bovie Medical Corporation | 2016 | 2 |
| +2 | K161558 | Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating… | Bovie Medical Corporation | 2016 | 3 |
| +2 | K231126 | Eblator Device | E Surgical, LLC | 2023 | — |
| +3 | K251899 | E Blator | New Deantronics Taiwan, Ltd. | 2025 | — |
| +1 | K173740 | Reprocessed DePuy Mitek Ablation Wand | Renovo, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K041810 | Serfas Energy SystemSummary page 3…ill have the same indication as the following electrodes currently on the market: > Serfas RF System: K041810 Safety and Verification and Validation of the VAPR Electrodes included performance Performance testi… | 2004 |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 3 companies; a new generation was cleared every 5 months on median.
- 3 of the 17 ancestors have a recall of any class.
- Of its descendants, K152777 (Bovie Medical Corporation, 2016) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K041810.
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?
VAPR VUE Radiofrequency system The Mitek VAPR VUE Radiofrequency System is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery. VAPR II Electrosurgical system The Mitek VAPR II Electrode System, when used with a VAPR M Electrode, is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft…
Read the full statement (218 words)
VAPR VUE Radiofrequency system
The Mitek VAPR VUE Radiofrequency System is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery.
VAPR II Electrosurgical system
The Mitek VAPR II Electrode System, when used with a VAPR M Electrode, is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery.
VAPR III Electrosurgical system
The VAPR III Electrode System, when used with a VAPR M Electrode, is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.
VAPR CoolPulse Electrodes (CP90, CP90 with Handcontrol)
The DePuy Mitek VAPR Electrodes for use with the VAPR VUE Radiofrequency System are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.
VAPR Suction Electrodes (P90, LDS and LPS Electrode)
The VAPR LD and LP Suction Electrodes, when used with the VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113545: Vapr Vue Generator, Vapr 3 Electrosurgical System, Vapr II Electrosurgical System Coolpluse 90 and Coolpluse 90 with Han.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113545
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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