510(k) · Cleared
ClearedAmbient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ArthroCare Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 29, 2016 as substantially equivalent to K083306 (Arthrocare Corp., 2008) after a 59-day review. Its family tree reaches back 13 generations to 2001.
- Decided
- Sep 29, 2016
- Review
- 59 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K011083 (2001). 25 ancestors in all, the oldest K000778 (2000). No later device cites it as a predicate yet.
- Root · 13 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 9 generations between
- 3 generations backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
- 2 generations backK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 1 generation backK083306 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- This deviceK162126 Ambient KVac Wand with Integrated Finger Switches (Ambient KVac…ArthroCare Corporation · 2016
Show all 13 generations
- Root · 13 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 12 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 11 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 10 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 9 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 8 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- 7 generations backK052686 Arthrocare ArthrowandsArthrocare Corp. · 2005
- 6 generations backK070958 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2007
- 5 generations backK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 4 generations backK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 3 generations backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
- 2 generations backK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 1 generation backK083306 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- This deviceK162126 Ambient KVac Wand with Integrated Finger Switches (Ambient KVac…ArthroCare Corporation · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −12 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −11 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −10 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −9 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −8 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| −7 | K052686 | Arthrocare Arthrowands | Arthrocare Corp. | 2005 | — |
| −6 | K070958 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −5 | K071963 | Modification to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −4 | K072865 | Modificaton to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −3 | K082323 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | — |
| −2 | K082980 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 12 |
| −1 | K083306 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 1 |
| 0 (this device) | K162126 | Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac… | ArthroCare Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083306 | Modification to Arthrocare ArthrowandsSummary page 5…gical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Regulation Number: 21 CFR 878.4400 Predicate Device K083306 Ambient Super MultiVac Wand with Integrated Finger Switches (IFS) of the ArthroCare ArthroWands Famil… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 2 companies; a new generation was cleared every 5 months on median.
- 4 of the 25 ancestors have a recall of any class.
- 7 other devices also cite its predicate K083306.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 KVac Wands (Ambient® KVac™ Wand with Integrated Finger Switches and KVac™ Integrated Cable Wand) are indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Joint — Ablation/Debridement — Excision/Resection — Coagulation All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow) Ablation/Debridement: Articular Cartilage; Bursectomy; Chondroplasty; Fascia; Ligament; Scar…
Read the full statement (136 words)
The KVac Wands (Ambient® KVac™ Wand with Integrated Finger Switches and KVac™ Integrated Cable Wand) are indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
Joint — Ablation/Debridement — Excision/Resection — Coagulation
All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow)
Ablation/Debridement: Articular Cartilage; Bursectomy; Chondroplasty; Fascia; Ligament; Scar Tissue; Soft Tissue; Synovectomy; Tendon
Excision/Resection: Articular Labrum; Capsule; Cysts; Ligament; Loose Bodies; Plica Removal; Scar Tissue; Soft Tissue; Synovial Membrane; Tendon
Coagulation: Articular Cartilage; Ligament; Tendon
Hip
Excision/Resection: Acetabular Labrum
Knee
Ablation/Debridement: ACL/PCL; Notchplasty
Excision/Resection: Capsular Release; Cartilage Flaps; Discoid Meniscus; Lateral Release; Meniscal Cystectomy; Meniscectomy; Villusectomy
Coagulation: ACL/PCL; Medial Retinaculum
Shoulder
Ablation/Debridement: Acromioplasty; Subacromial Decompression
Excision/Resection: Frozen Shoulder Release; Glenoidale Labrum
Coagulation: Glenohumeral Capsule; Rotator Cuff
Wrist
Excision/Resection: Triangular Fibrocartilage (TFCC)
Coagulation: Carpal Ligaments; Wrist Tendons
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162126: Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162126
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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