510(k) Report

510(k) · Cleared

Cleared

VAPR

K974022510(k) TraditionalCleared Jan 12, 199890-day reviewClass II21 CFR 878.4400

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

Mitek Products · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jan 12, 1998 after a 90-day review. The FDA summary names its predicate without a number. 28 later devices descend from it.

Decided
Jan 12, 1998
Review
90 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

28 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2001: 2 descendants cleared2004: 2 descendants cleared2002: 1 descendant cleared2008: 1 descendant cleared1999: 2 descendants cleared2006: 1 descendant cleared2012: 3 descendants cleared2007: 1 descendant cleared2017: 2 descendants cleared2016: 3 descendants cleared2010: 1 descendant cleared2014: 1 descendant cleared2025: 2 descendants cleared2015: 1 descendant cleared2018: 2 descendants cleared2023: 2 descendants cleared2024: 1 descendant cleared1995200020052010201520202025
  1. This deviceK974022 VAPRMitek Products · 1998
  2. Descendant · cites it directly · 17 of its ownK041810 Serfas Energy SystemStryker Endoscopy · 2004 · Recalled
  3. Descendant · cites it directly · 12 of its ownK992876 Vapr 2.3 MM Side Effect Electrode for Use with Vapr SystemMitek Products · 1999
  4. Descendant · cites it directly · 12 of its ownK992406 Vapr 2.3MM End Effect Electrode for Use with Vapr SystemMitek Products · 1999
  5. Descendant · 2 generations on · 10 of its ownK041135 Vapr 3 Electrosurgical System and Vapr LD and LP Suction ElectrodesDepuy Mitek, A Johnson & Johnson Company · 2004
  6. 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

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

1999: 22001: 22002: 12004: 22006: 12007: 12008: 12010: 12012: 32014: 12015: 12016: 32017: 22018: 22023: 22024: 12025: 2
1999high 3 (2012) · low 0 (2000)2026

Most influential descendants

Showing 5 of 28 · See all
  • K041810Serfas Energy SystemStryker Endoscopy · 2004 · cites it directly17descendants
  • K992876Vapr 2.3 MM Side Effect Electrode for Use with Vapr SystemMitek Products · 1999 · cites it directly12descendants
  • K992406Vapr 2.3MM End Effect Electrode for Use with Vapr SystemMitek Products · 1999 · cites it directly12descendants
  • K041135Vapr 3 Electrosurgical System and Vapr LD and LP Suction ElectrodesDepuy Mitek, A Johnson & Johnson Company · 2004 · 2 generations on10descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K974022VAPRMitek Products1998—
+1K041810Serfas Energy SystemStryker Endoscopy20043
+1K992876Vapr 2.3 MM Side Effect Electrode for Use with Vapr SystemMitek Products1999—
+1K992406Vapr 2.3MM End Effect Electrode for Use with Vapr SystemMitek Products1999—
+2K041135Vapr 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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
200120
200210
200420
200610
200710
200810
201010
201230
201410
201510
201630
201720
201820
202320
202410
202520
FIG. 1 — Lineage of K974022, 1998–2025Source: 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 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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*—Oratec Interventions™ Model ORA 50 Electrothermal Generator and Accessories
Named without a submission number
—

What descends from it? (28)

See all 28

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

NumberDeviceApplicantDecidedDescendants
K041810Serfas Energy SystemStryker Endoscopy200417
K992876Vapr 2.3 MM Side Effect Electrode for Use with Vapr SystemMitek Products199912
K992406Vapr 2.3MM End Effect Electrode for Use with Vapr SystemMitek Products199912
K0826433.5 MM Side Effect Electrode with Integrated Handpiece, Model 227301, 3.5 MM Angled Side…Depuy Mitek, A Johnson & Johnson Company20089
K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp.20011
K012640Electrosurgical Cutting and Coagulation Accessories, Electrosurgical WandsMedical Instruments Technology, Inc.20020
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?

  • Of its descendants, K041810 (Stryker Endoscopy, 2004) has gone furthest, with 17 descendants of its own.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The Mitek Vapr Generator and Accessories, in combination with Vapr thermal / coagulating probes (electrodes), is designed for general surgical use, including orthopaedic and arthroscopic applications of resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues.

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

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 GEI

The GEI category page

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  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
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https://510kreport.com/device/K974022 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974022: VAPR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974022

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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