510(k) · Cleared
ClearedVapr P50 Suction Electrode Vapr S90 Suction Electrode Vapr P50 Suction Electrode with Handcontrols VAPRS90 Suction Elect
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 Nov 5, 2012 after an 88-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Nov 5, 2012
- Review
- 88 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK122425 Vapr P50 Suction Electrode Vapr S90 Suction Electrode Vapr P50…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 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K122425 | Vapr P50 Suction Electrode Vapr S90 Suction Electrode Vapr P50 Suction… | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (5)
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 |
|---|---|---|---|
| * | — | VAPR LIDS Electrode Named without a submission number | |
| * | — | VAPR LPS Electrode Named without a submission number | |
| * | — | VAPR P90 Electrode Named without a submission number | |
| * | — | VAPR CP90 Electrode Named without a submission number | |
| * | — | VAPR CP90 Electrode w/Handcontrols Named without a submission number |
What descends from it? (6)
3 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?
- Of its descendants, K152777 (Bovie Medical Corporation, 2016) has gone furthest, with 3 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. 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 DePuy Mitek VAPR Electrodes for use with the VAPR System are intended for resection,
ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in
patients requiring arthroscpic surgery of the knee, shoulder, hip, ankle, elbow and wrist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122425: Vapr P50 Suction Electrode Vapr S90 Suction Electrode Vapr P50 Suction Electrode with Handcontrols VAPRS90 Suction Elect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122425
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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