510(k) · Cleared
ClearedVapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214
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 Jun 18, 2010 as substantially equivalent to K041135 (Depuy Mitek, A Johnson & Johnson Company, 2004) and 6 other predicates after a 105-day review. Its family tree reaches back 10 generations to 1993. 8 later devices descend from it.
- Decided
- Jun 18, 2010
- Review
- 105 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 10 generations to K931783 (1993). 49 ancestors in all, the oldest K852143 (1985). 8 later devices descend from it, 5 citing it directly.
- Root · 10 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 6 generations between
- 3 generations backK033135 Stryker Wireless Universal Footswitch SystemStryker Endoscopy · 2004
- 2 generations backK053510 IR Wireless Foot SwitchLinemaster Switch Corp. · 2006 · Recalled
- 1 generation backK083161 Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter…Conmed Linvatec · 2009
- This deviceK100638 Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless…Depuy Mitek, A Johnson & Johnson Company · 2010
- 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
Show all 10 generations
- Root · 10 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 9 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 8 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 7 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 6 generations backK990691 Hermes Operating Room Control CenterComputer Motion, Inc. · 1999
- 5 generations backK991444 Hermes Control Center, with Control of the Aesop 3000HR (Hermes…Computer Motion, Inc. · 1999
- 4 generations backK022393 Merdoc SystemStryker Endoscopy · 2003
- 3 generations backK033135 Stryker Wireless Universal Footswitch SystemStryker Endoscopy · 2004
- 2 generations backK053510 IR Wireless Foot SwitchLinemaster Switch Corp. · 2006 · Recalled
- 1 generation backK083161 Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter…Conmed Linvatec · 2009
- This deviceK100638 Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless…Depuy Mitek, A Johnson & Johnson Company · 2010
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · 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 |
|---|---|---|---|---|---|
| −10 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −9 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −8 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −7 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −6 | K990691 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1999 | — |
| −5 | K991444 | Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready). | Computer Motion, Inc. | 1999 | — |
| −4 | K022393 | Merdoc System | Stryker Endoscopy | 2003 | — |
| −3 | K033135 | Stryker Wireless Universal Footswitch System | Stryker Endoscopy | 2004 | — |
| −2 | K053510 | IR Wireless Foot Switch | Linemaster Switch Corp. | 2006 | 2 |
| −1 | K083161 | Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100) | Conmed Linvatec | 2009 | — |
| 0 (this device) | K100638 | Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch… | Depuy Mitek, A Johnson & Johnson Company | 2010 | — |
| +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 |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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? (7)
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 |
|---|---|---|---|
| * | K041135 | Vapr 3 Electrosurgical System and Vapr LD and LP Suction ElectrodesSummary page 1…dicate Device(s) The proposed VAPR VULE Radiofrequency System is substantially equivalent to: *K041135: VAPRIITM (May 10, 2004) The proposed VAPR VUE Radiofrequency System is also similar to:… | 2004 |
| * | K083161 | Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100)Summary page 2…UE System & Electrodes The proposed Wireless Footswitch issubstantially equivalent to: * K083161: Conl~ed Linvatc Zen Wireless Footswitch * K053510: Linemaster IRWireless Footswitch System… | 2009 |
| * | K053510 | IR Wireless Foot SwitchSummary page 2…reless Footswitch issubstantially equivalent to: * K083161: Conl~ed Linvatc Zen Wireless Footswitch * K053510: Linemaster IRWireless Footswitch System * K033135: Stryker Wireless Universal Footswitch… | 2006 |
| * | K033135 | Stryker Wireless Universal Footswitch SystemSummary page 2…K083161: Conl~ed Linvatc Zen Wireless Footswitch * K053510: Linemaster IRWireless Footswitch System * K033135: Stryker Wireless Universal Footswitch The proposed P90 and CP9O Electrodes are substantially equ… | 2004 |
| * | K002422 | Varpr 3.5MM 90 Suction Electrode for Use with Vapr SystemSummary page 2…r Wireless Universal Footswitch The proposed P90 and CP9O Electrodes are substantially equivalent to: * K002422: VAPR 900 Suction Electrode (August 31, 2000) * K041135: VAPR [PS Electrode (May 10, 2004)… | 2000 |
| * | K082643 | 3.5 MM Side Effect Electrode with Integrated Handpiece, Model 227301, 3.5 MM Angled Side…Summary page 2…K002422: VAPR 900 Suction Electrode (August 31, 2000) * K041135: VAPR [PS Electrode (May 10, 2004) * K082643: VAPR Electrodes with Handpieces (December 19, 2008) The proposed P50 Electrode issubstantially e… | 2008 |
| * | K992876 | Vapr 2.3 MM Side Effect Electrode for Use with Vapr SystemSummary page 2…ctrodes with Handpieces (December 19, 2008) The proposed P50 Electrode issubstantially equivalent to: • K992876: The 2.3 Wedge Effect Electrode ( September 24, 1999) * K041135: VAPR [IPS Electrode (May 10, 2… | 1999 |
| † | K031085 | Gyrus Plasmakinetic Superpulse System (Generator, Accessories) | 2003 |
What descends from it? (8)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152777 | Bovie Disposable Bipolar Ablator | 2016 | 3 |
| K173740 | Reprocessed DePuy Mitek Ablation Wand | 2018 | 0 |
| K143475 | VAPR Tripolar Suction Electrode | 2015 | 0 |
| K140896 | Vapr Arctic Suction Electrode | 2014 | 0 |
| K120095 | Side Effect with Hand Controls, Hook Electrode with Hand Controls, 2.3 Wedge Electrode… | 2012 | 0 |
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 17 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 8 of the 49 ancestors have a recall of any class.
- Of its descendants, K152777 (Bovie Medical Corporation, 2016) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K041135.
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?
The DePuy Mitek VAPR Electrodes for use with all VAPR Electrosurgical Systems are intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and wrist. The Mitek VAPR VUE Radiofrequency System is intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft…
Read the full statement (127 words)
The DePuy Mitek VAPR Electrodes for use with all VAPR Electrosurgical Systems are intended
for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation
of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and
wrist.
The Mitek VAPR VUE Radiofrequency System is intended for resection, ablation and excision of
soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring
arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.
The DePuy Mitek VAPR Electrodes for use with the VAPR VUE Radiofrequency System are
intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and
coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder,
ankle, elbow, and wrist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100638: Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100638
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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