510(k) Report

510(k) · Cleared

Cleared

Vapr 2.3 MM Side Effect Electrode for Use with Vapr System

K992876510(k) SpecialCleared Sep 24, 199929-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

Mitek Products · HRX Arthroscope

Cleared on Sep 24, 1999 as substantially equivalent to K974022 (Mitek Products, 1998) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 1996. 12 later devices descend from it.

Decided
Sep 24, 1999
Review
29 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K963783 (1996). 2 ancestors in all. 12 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2001: 1 descendant cleared2004: 1 descendant cleared2008: 1 descendant cleared2010: 1 descendant cleared2012: 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. · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K963783 · Mitek Electrosurgical System for Arthroscopic Use · ETHICON, Inc. · 19960
  1. Root · 1 generation backK963783 Mitek Electrosurgical System for Arthroscopic UseETHICON, Inc. · 1996
  2. This deviceK992876 Vapr 2.3 MM Side Effect Electrode for Use with Vapr SystemMitek Products · 1999
  3. Descendant · cites it directly · 10 of its ownK041135 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

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2001: 12004: 12008: 12010: 12012: 12014: 12015: 12016: 22018: 12023: 12025: 1
2001high 2 (2016) · low 0 (2002)2026

Most influential descendants

Showing 5 of 12 · See all
  • K041135Vapr 3 Electrosurgical System and Vapr LD and LP Suction ElectrodesDepuy Mitek, A Johnson & Johnson Company · 2004 · cites it directly10descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K963783Mitek Electrosurgical System for Arthroscopic UseETHICON, Inc.1996—
0 (this device)K992876Vapr 2.3 MM Side Effect Electrode for Use with Vapr SystemMitek Products1999—
+1K041135Vapr 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

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200410
200810
201010
201210
201410
201510
201620
201810
202310
202510
FIG. 1 — Lineage of K992876, 1996–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K974022VAPR
Summary page 1
…ion: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class IL Product Code: GEI (21 CFR 878.4400) Predicate Devices: K974022 - Mitek VAPR™ T Thermal Electrode K963783 — Mitek VAPR™ System Product Description: The devices described in this 510(k) are ste…
Mitek Products1998—
*K963783Mitek Electrosurgical System for Arthroscopic Use
Summary page 1
…al Food, Drug, and Cosmetic Act, the device classification is Class IL Product Code: GEI (21 CFR 878.4400) Predicate Devices: K974022 - Mitek VAPR™ T Thermal Electrode K963783 — Mitek VAPR™ System Product Description: The devices described in this 510(k) are sterile, disposable electrodes designed for u…
ETHICON, Inc.1996—

Also cleared against K974022: 6 other devices →

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K041135Vapr 3 Electrosurgical System and Vapr LD and LP Suction ElectrodesDepuy Mitek, A Johnson & Johnson Company200410
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
K012679Reprocessed RF Arthroscopy ProbesSterilmed, Inc.20010

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K041135 (Depuy Mitek, A Johnson & Johnson Company, 2004) has gone furthest, with 10 descendants of its own.
  • 6 other devices also cite its predicate K974022.

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 Mitek VAPR™ System, when used with a VAPR™ 2.3mm Side Effect Electrode, 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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K974022

6 other devices cite 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
  • K041810Serfas Energy SystemStryker Endoscopy · 20043 recalls
  • K012640Electrosurgical Cutting and Coagulation Accessories, Electrosurgical WandsMedical Instruments Technology, Inc. · 20021 recall
  • K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp. · 2001
  • K012679Reprocessed RF Arthroscopy ProbesSterilmed, Inc. · 20011 recall
  • K992406Vapr 2.3MM End Effect Electrode for Use with Vapr SystemMitek Products · 1999

More from Mitek Products

30 FDA decisions under this applicant name. See the company

  • K013572Mitek Biocryl Interference ScrewsMitek Products · 2002
  • K013781Rididfix 2.7MM BTB Cross Pin KitMitek Products · 2002
  • K002639Bioknotless AnchorMitek Products · 20012 recalls
  • K010633Rigidfix Soft Tissue Acl Crosspin SystemMitek Products · 2001
  • K002406Mitek 2GII Meniscal Repair SystemMitek Products · 2001

Recent decisions in HRX

The HRX category page

  • K263208Vantage Lumbar Decompression KitSurGenTec, LLC · 2026
  • K260156TruVision Single-Use 1.9mm Arthroscopy SystemNexus CMF, LLC · 2026
  • K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd. · 2026
  • K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KG · 2026
  • K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLC · 2026

https://510kreport.com/device/K992876 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992876: Vapr 2.3 MM Side Effect Electrode for Use with Vapr System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992876

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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