510(k) · Cleared
ClearedArthrocare System
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 Aug 21, 2003 as substantially equivalent to K030551 (Arthrocare Corp., 2003) after an 8-day review. Its family tree reaches back 4 generations to 2001. 51 later devices descend from it.
- Decided
- Aug 21, 2003
- Review
- 8 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011083 (2001). 5 ancestors in all. 51 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 3 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 2 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 1 generation backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- This deviceK032504 Arthrocare SystemArthrocare Corp. · 2003
- Descendant · cites it directly · 43 of its ownK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- Descendant · 2 generations on · 26 of its ownK052686 Arthrocare ArthrowandsArthrocare Corp. · 2005
- Descendant · 3 generations on · 22 of its ownK070958 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2007
- Descendant · 4 generations on · 21 of its ownK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- Descendant · 5 generations on · 20 of its ownK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K033584Arthrocare ArthrowandsArthrocare Corp. · 2003 · cites it directly43descendants
- K052686Arthrocare ArthrowandsArthrocare Corp. · 2005 · 2 generations on26descendants
- K070958Modification to Arthrocare ArthrowandsArthrocare Corp. · 2007 · 3 generations on22descendants
- K071963Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007 · 4 generations on21descendants
- K072865Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007 · 5 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −3 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −2 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −1 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| 0 (this device) | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| +1 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| +2 | K052686 | Arthrocare Arthrowands | Arthrocare Corp. | 2005 | — |
| +3 | K070958 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| +4 | K071963 | Modification to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| +5 | K072865 | Modificaton to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2012 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 7 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot Control… | 2003 |
What descends from it? (51)
See all 514 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 2 years and passes through 1 company; a new generation was cleared every 5 months on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K033584 (Arthrocare Corp., 2003) has gone furthest, with 43 descendants of its own.
- 2 other devices also cite its predicate K030551.
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 MhroCare System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures: ACUPCL — Knee Acromioplasty — Shoulder Articular Cartilage — All Joints Bursectomy — All Joints Chondroplasty — All Joints Facia — All Joints Ligament — All Joints Notchplasty — Knee Scar Tissue — All Joints SoftTissue — All Joints Subacromial Decompression — Shoulder Synovectomy — All Joints…
Read the full statement (198 words)
The MhroCare System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:
ACUPCL — Knee
Acromioplasty — Shoulder
Articular Cartilage — All Joints
Bursectomy — All Joints
Chondroplasty — All Joints
Facia — All Joints
Ligament — All Joints
Notchplasty — Knee
Scar Tissue — All Joints
SoftTissue — All Joints
Subacromial Decompression — Shoulder
Synovectomy — All Joints
Tendon — All Joints
Acetabular Labrum — Hip
Articular Labrum — All Joints
Capsule — All Joints
Capsular Release — Knee
Cartilage Flaps — Knee
cysts — All Joints
Discoid Meniscus — Knee
Frozen Shoulder Release — Shoulder
Glenoidale Labrum — Shoulder
Lateral Release — Knee
Ligainent — All Joints
Loose Bodies — All Joints
Meniscal Cystectomy — Knee
Meniscectomy — Knee
Plica Removal — All Joints
ScarTissue — All Joints
SoftTissue — All Joints
Synovial Membrane — All Joints
Tendon — All Joints
Triangular Fibrocartilage (TFCC) — Wrist
Villusectomy — Knee
ACUPCL — Knee
Articular Cartilage — All Joints
Carpal Ligaments — Wrist
Glenohumeral Capsule — Shoulder
Ligament — All Joints
Medial Retinaculum — Knee
Rotator Cuff — Shoulder
Tendon — All Joints
Wrist Tendons — wrist
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032504: Arthrocare System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032504
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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