510(k) · Cleared
ClearedArthrocare Controller, Cable, Foot Control, Power Cord, Wands, Models H0970-02, H2000-04, H2000-05, H0970-06
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrocare Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 1, 2004 as substantially equivalent to K020832 (Arthrocare Corp., 2002) and 1 other predicate after a 19-day review. Its family tree reaches back 3 generations to 2000. 24 later devices descend from it.
- Decided
- Mar 1, 2004
- Review
- 19 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000778 (2000). 10 ancestors in all. 24 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK000778 Entec Reflex Wand 55, Model E4055-01, E4045-01Arthrocare Corp. · 2000
- 2 generations backK011634 Arthrocare Controller, Model H2000; Arthrocare Cable, Model…Arthrocare Corp. · 2001
- 1 generation backK020832 Arthrocare Controller, Arthrocare Cable, Foot Control, Power Cord…Arthrocare Corp. · 2002
- This deviceK040338 Arthrocare Controller, Cable, Foot Control, Power Cord, Wands…Arthrocare Corp. · 2004
- Descendant · cites it directly · 21 of its ownK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- Descendant · 2 generations on · 20 of its ownK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- Descendant · 3 generations on · 19 of its ownK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
- Descendant · 4 generations on · 17 of its ownK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- Descendant · 5 generations on · 14 of its ownK083306 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K071963Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007 · cites it directly21descendants
- K072865Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007 · 2 generations on20descendants
- K082323Arthrocare ArthrowandsArthrocare Corp. · 2008 · 3 generations on19descendants
- K082980Arthrocare ArthrowandsArthrocare Corp. · 2008 · 4 generations on17descendants
- K083306Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · 5 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000778 | Entec Reflex Wand 55, Model E4055-01, E4045-01 | Arthrocare Corp. | 2000 | — |
| −2 | K011634 | Arthrocare Controller, Model H2000; Arthrocare Cable, Model H0970-02… | Arthrocare Corp. | 2001 | — |
| −1 | K020832 | Arthrocare Controller, Arthrocare Cable, Foot Control, Power Cord, Wands | Arthrocare Corp. | 2002 | — |
| 0 (this device) | K040338 | Arthrocare Controller, Cable, Foot Control, Power Cord, Wands, Models… | Arthrocare Corp. | 2004 | — |
| +1 | K071963 | Modification to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| +2 | K072865 | Modificaton to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| +3 | K082323 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | — |
| +4 | K082980 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 12 |
| +5 | K083306 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K020832 | Arthrocare Controller, Arthrocare Cable, Foot Control, Power Cord, WandsSummary page 1…Device and Accessories (21 CFR 878.4400) Predicate Devices ArthroCare ® System 2000 K020832 and K030954 Product Description The ArthroCare System is a bipolar, high frequency electrosurgical system consisting of three co… | 2002 |
| * | K030954 | Arthrocare Percd SpinewandSummary page 1…Device and Accessories (21 CFR 878.4400) Predicate Devices ArthroCare ® System 2000 K020832 and K030954 Product Description The ArthroCare System is a bipolar, high frequency electrosurgical system consisting of three components: an… | 2003 |
What descends from it? (24)
See all 242 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K071963 (Arthrocare Corp., 2007) has gone furthest, with 21 descendants of its own.
- 2 other devices also cite its predicate K020832.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 ArthroCare System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures.
The ArthroCare System is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040338 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040338: Arthrocare Controller, Cable, Foot Control, Power Cord, Wands, Models H0970-02, H2000-04, H2000-05, H0970-06.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040338
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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