510(k) Report

510(k) · Cleared

Cleared

Vapr 3 Electrosurgical System and Vapr LD and LP Suction Electrodes

K041135510(k) SpecialCleared May 10, 200410-day reviewClass II21 CFR 888.1100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Depuy Mitek, A Johnson & Johnson Company · HRX Arthroscope

Cleared on May 10, 2004 as substantially equivalent to K002402 (Mitek Products, 2000) and 2 other predicates after a 10-day review. Its family tree reaches back 2 generations to 1996. 10 later devices descend from it.

Decided
May 10, 2004
Review
10 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K963783 (1996). 5 ancestors in all. 10 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors1998: 1 other ancestor2012: 1 descendant cleared2008: 1 descendant cleared2010: 1 descendant cleared2014: 1 descendant cleared2016: 2 descendants cleared2015: 1 descendant cleared2018: 1 descendant cleared2023: 1 descendant cleared2025: 1 descendant clearedK963783 · Mitek Electrosurgical System for Arthroscopic Use · ETHICON, Inc. · 1996K992876 · Vapr 2.3 MM Side Effect Electrode for Use with Vapr System · Mitek Products · 19991995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K992876 · Vapr 2.3 MM Side Effect Electrode for Use with Vapr System · Mitek Products · 1999K963783 · Mitek Electrosurgical System for Arthroscopic Use · ETHICON, Inc. · 19960
  1. Root · 2 generations backK963783 Mitek Electrosurgical System for Arthroscopic UseETHICON, Inc. · 1996
  2. 1 generation backK992876 Vapr 2.3 MM Side Effect Electrode for Use with Vapr SystemMitek Products · 1999
  3. This deviceK041135 Vapr 3 Electrosurgical System and Vapr LD and LP Suction ElectrodesDepuy Mitek, A Johnson & Johnson Company · 2004
  4. Descendant · cites it directly · 9 of its ownK082643 3.5 MM Side Effect Electrode with Integrated Handpiece, Model…Depuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
  5. Descendant · cites it directly · 8 of its ownK100638 Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless…Depuy Mitek, A Johnson & Johnson Company · 2010
  6. Descendant · 2 generations on · 3 of its ownK152777 Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · Recalled
  7. Descendant · 3 generations on · 2 of its ownK161558 Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and…Bovie Medical Corporation · 2016 · Recalled
  8. Descendant · 3 generations on · 1 of its ownK231126 Eblator DeviceE Surgical, LLC · 2023

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2008: 12010: 12012: 12014: 12015: 12016: 22018: 12023: 12025: 1
2008high 2 (2016) · low 0 (2009)2026

Most influential descendants

Showing 5 of 10 · See all
  • K0826433.5 MM Side Effect Electrode with Integrated Handpiece, Model 227301, 3.5 MM Angled Side…Depuy Mitek, A Johnson & Johnson Company · 2008 · cites it directly9descendants
  • K100638Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214Depuy Mitek, A Johnson & Johnson Company · 2010 · cites it directly8descendants
  • K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · 2 generations on3descendants
  • K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…Bovie Medical Corporation · 2016 · 3 generations on2descendants
  • K231126Eblator DeviceE Surgical, LLC · 2023 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K963783Mitek Electrosurgical System for Arthroscopic UseETHICON, Inc.1996—
−1K992876Vapr 2.3 MM Side Effect Electrode for Use with Vapr SystemMitek Products1999—
0 (this device)K041135Vapr 3 Electrosurgical System and Vapr LD and LP Suction ElectrodesDepuy Mitek, A Johnson & Johnson Company2004—
+1K0826433.5 MM Side Effect Electrode with Integrated Handpiece, Model 227301, 3.5 MM…Depuy Mitek, A Johnson & Johnson Company20082
+1K100638Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch…Depuy Mitek, A Johnson & Johnson Company2010—
+2K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation20162
+3K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating…Bovie Medical Corporation20163
+3K231126Eblator DeviceE Surgical, LLC2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
201210
201410
201510
201620
201810
202310
202510
FIG. 1 — Lineage of K041135, 1996–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 HRX? 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 HRX device

  1. #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K002402Vapr TC Electrode for Use with Vapr II Electrosurgical System
Summary page 1
…des Substantial Equivalence VAPR 3 Electrosurgical System is substantially equivalent to theVAPR II Electrosurgical System (K002402, 8/31/2000). The VAPR LD Suction Electrode is substantially equivalent to the…
Mitek Products2000—
*K992876Vapr 2.3 MM Side Effect Electrode for Use with Vapr System
Summary page 1
…0). The VAPR LD Suction Electrode is substantially equivalent to the VAPR 2.3 Side Effect Electrode (K992876, 9/24/1999) and the VAPR 3.5 Suction Electrode (K002422, 8/31/2000)…
Mitek Products1999—
*K002422Varpr 3.5MM 90 Suction Electrode for Use with Vapr System
Summary page 1
…valent to the VAPR 2.3 Side Effect Electrode (K992876, 9/24/1999) and the VAPR 3.5 Suction Electrode (K002422, 8/31/2000) The VAPR LP Suction Electrode is substantially equivalent to the…
Mitek Products2000—
*—VAPR LD Suction Electrode
Named without a submission number
—

Also cleared against K002402: 1 other device →

What descends from it? (10)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K0826433.5 MM Side Effect Electrode with Integrated Handpiece, Model 227301, 3.5 MM Angled Side…Depuy Mitek, A Johnson & Johnson Company20089
K100638Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214Depuy Mitek, A Johnson & Johnson Company20108
K120095Side Effect with Hand Controls, Hook Electrode with Hand Controls, 2.3 Wedge Electrode…Depuy Mitek, A Johnson & Johnson Company20120

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 8 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K082643 (Depuy Mitek, A Johnson & Johnson Company, 2008) has gone furthest, with 9 descendants of its own.
  • 1 other device also cites its predicate K002402.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRX

9in 2025

2007: 72008: 92009: 112010: 92011: 32012: 112013: 122014: 92015: 42016: 82017: 42018: 122019: 122020: 72021: 72022: 32023: 42024: 62025: 92026 (partial year): 7
2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007: 89 days median2008: 115 days median2009: 139 days median2010: 114 days median2011: 84 days median2012: 102 days median2013: 90 days median2014: 140 days median2015: 132 days median2016: 89 days median2017: 97 days median2018: 101 days median2019: 45 days median2020: 141 days median2021: 57 days median2022: 89 days median2023: 249 days median2024: 110 days median2025: 107 days median2026 (partial year): 217 days median
2007high 249 (2023) · low 45 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRX

1in 2024

2007: 32008: 132009: 232010: 122011: 62013: 42015: 72018: 12021: 32024: 1
2007high 23 (2009) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRX

2,076in 2025

2007: 4212008: 4412009: 5582010: 6122011: 6312012: 7782013: 6782014: 8022015: 7632016: 4692017: 9342018: 1,5812019: 1,6762020: 1,7062021: 1,9082022: 1,4062023: 1,8522024: 2,4272025: 2,076
2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20077893421
2008911513441
20091113923558
2010911412612
20113846631
2012111020778
201312904678
201491400802
201541327763
20168890469
20174970934
20181210111,581
2019124501,676
2020714101,706
202175731,908
202238901,406
2023424901,852
2024611012,427
2025910702,076
202672170—

What is it indicated for?

The VAPR 3 Electrosurgical System, when used with a VAPR Electrode, is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, andle, elbow and wrist.

The VAPR LD and LP Suction Electrodes, when used with the VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, andle, elbow and wrist.

Indications for use as stated in the FDA summary.

Also cleared against K002402

1 other device cites the same predicate.

  • K0826433.5 MM Side Effect Electrode with Integrated Handpiece, Model 227301, 3.5 MM Angled Side Effect Electrode…Depuy Mitek, A Johnson & Johnson Company · 20082 recalls

More from Depuy Mitek, A Johnson & Johnson Company

58 FDA decisions under this applicant name. See the company

  • K143660Milagro / Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2015
  • K1425744.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3…Depuy Mitek, A Johnson & Johnson Company · 2014
  • K140896Vapr Arctic Suction ElectrodeDepuy Mitek, A Johnson & Johnson Company · 2014
  • K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek Anchor with Permacord…Depuy Mitek, A Johnson & Johnson Company · 2014
  • K1337944.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix Advance BR Anchor…Depuy Mitek, A Johnson & Johnson Company · 2014

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The HRX category page

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https://510kreport.com/device/K041135 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041135: Vapr 3 Electrosurgical System and Vapr LD and LP Suction Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041135

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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