510(k) · Cleared
ClearedRF20000a Controller, FLOW 50 Wand
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 Oct 23, 2015 as substantially equivalent to K082666 (Arthrocare Corp., 2008) and 1 other predicate after a 347-day review. Its family tree reaches back 13 generations to 2001. 4 later devices descend from it.
- Decided
- Oct 23, 2015
- Review
- 347 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K011083 (2001). 27 ancestors in all, the oldest K000778 (2000). 4 later devices descend from it, 1 citing it directly.
- 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 deviceK143235 RF20000a Controller, FLOW 50 WandArthroCare Corporation · 2015
- Descendant · cites it directly · 3 of its ownK162074 Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation · 2016
- Descendant · 2 generations on · 2 of its ownK183346 FLOW 90 WandArthroCare Corporation · 2019
- Descendant · 3 generations on · 1 of its ownK240964 FLOW 90? WandArthroCare Corporation · 2024
- Descendant · 4 generations on · 0 of its ownK254122 FLOW FLEXTEND Wand (72290039)ArthroCare Corporation · 2026
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 deviceK143235 RF20000a Controller, FLOW 50 WandArthroCare Corporation · 2015
Most influential descendants
Showing 4 of 4 · See all- K162074Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation · 2016 · cites it directly3descendants
- K183346FLOW 90 WandArthroCare Corporation · 2019 · 2 generations on2descendants
- K240964FLOW 90? WandArthroCare Corporation · 2024 · 3 generations on1descendant
- K254122FLOW FLEXTEND Wand (72290039)ArthroCare Corporation · 2026 · 4 generations on0descendants
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) | K143235 | RF20000a Controller, FLOW 50 Wand | ArthroCare Corporation | 2015 | — |
| +1 | K162074 | Werewolf RF20000 Controller, FLOW 50 Wand | ArthroCare Corporation | 2016 | — |
| +2 | K183346 | FLOW 90 Wand | ArthroCare Corporation | 2019 | — |
| +3 | K240964 | FLOW 90? Wand | ArthroCare Corporation | 2024 | — |
| +4 | K254122 | FLOW FLEXTEND Wand (72290039) | ArthroCare Corporation | 2026 | — |
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 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082666 | Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot Control, Power…Summary page 5…uct Code: GEI Regulation Number: 21 CFR 878.4400 Predicate Devices ArthroCare® System 12000 (Quantum 2) K082666 ArthroCare ArthroWands® (Ambient Super MultiVac 50) K083306 Description RF20000a Coblation S… | 2008 |
| * | K083306 | Modification to Arthrocare ArthrowandsSummary page 5…stem 12000 (Quantum 2) K082666 ArthroCare ArthroWands® (Ambient Super MultiVac 50) K083306 Description RF20000a Coblation System The RF20000a Coblation System is an electrosurgical system consisting of a bipolar radiofr… | 2008 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162074 | Werewolf RF20000 Controller, FLOW 50 Wand | 2016 | 3 |
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 14 years and passes through 2 companies; a new generation was cleared every 5 months on median.
- 4 of the 27 ancestors have a recall of any class.
- Of its descendants, K162074 (ArthroCare Corporation, 2016) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K082666.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 RF20000a Coblation System, comprised of the FLOW 50 Wand and the RF20000a Controller, is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures: All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow) Ablation/Debridement: Articular Cartilage; Bursectomy; Chondroplasty; Fascia; Ligament; Scar Tissue; Soft Tissue; Synovectomy; Tendon…
Read the full statement (112 words)
The RF20000a Coblation System, comprised of the FLOW 50 Wand and the RF20000a Controller, is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures:
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
Hip
Excision/Resection: Acetabular Labrum; Capsular Release
Knee
Ablation/Debridement: ACL/PCL; Notchplasty
Excision/Resection: Cartilage Flaps; Discoid Meniscus; Lateral Release; Meniscal Cystectomy; Meniscectomy; Villusectomy
Shoulder
Ablation/Debridement: Acromioplasty; Subacromial Decompression
Excision/Resection: Frozen Shoulder Release; Glenoid Labrum
Wrist
Excision/Resection: Triangular Fibrocartilage (TFCC)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143235 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143235: RF20000a Controller, FLOW 50 Wand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143235
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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