510(k) · Cleared

Recalled · 2008

Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot Control; Power Cord; Wands

K030551510(k) SpecialCleared Mar 7, 200314-day reviewClass II21 CFR 878.4400Recalls 1

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

Arthrocare Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Mar 7, 2003 as substantially equivalent to K020557 (Arthrocare Corp., 2002) after a 14-day review. Its family tree reaches back 3 generations to 2001. 52 later devices descend from it. It has been recalled once.

Decided: Mar 7, 2003
Review: 14 days
Class: Class II
Product code: GEI
Recalls: 1
Predicates: 1

Its longest line of descent runs back 3 generations to K011083 (2001). 4 ancestors in all. 52 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 3 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
2 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
1 generation backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
This deviceK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003
Descendant · cites it directly · 51 of its ownK032504 Arthrocare SystemArthrocare Corp. · 2003
Descendant · 2 generations on · 43 of its ownK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
Descendant · 3 generations on · 26 of its ownK052686 Arthrocare ArthrowandsArthrocare Corp. · 2005
Descendant · 4 generations on · 22 of its ownK070958 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2007
Descendant · 5 generations on · 21 of its ownK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007

Showing 5 of 52 descendants. See all descendants

Descendants cleared per year

2003high 7 (2016) · low 0 (2010)2026

Most influential descendants

Showing 5 of 52 · See all

K032504Arthrocare SystemArthrocare Corp. · 2003 · cites it directly51descendants
K033584Arthrocare ArthrowandsArthrocare Corp. · 2003 · 2 generations on43descendants
K052686Arthrocare ArthrowandsArthrocare Corp. · 2005 · 3 generations on26descendants
K070958Modification to Arthrocare ArthrowandsArthrocare Corp. · 2007 · 4 generations on22descendants
K071963Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007 · 5 generations on21descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K011083	Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare…	Arthrocare Corp.	2001	—
−2	K013463	Arthrocare Arthro Wands, Enetec Evac Plasma Wand	Arthrocare Corp.	2001	—
−1	K020557	Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands	Arthrocare Corp.	2002	—
0 (this device)	K030551	Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot…	Arthrocare Corp.	2003	—
+1	K032504	Arthrocare System	Arthrocare Corp.	2003	—
+2	K033584	Arthrocare Arthrowands	Arthrocare Corp.	2003	1
+3	K052686	Arthrocare Arthrowands	Arthrocare Corp.	2005	—
+4	K070958	Modification to Arthrocare Arthrowands	Arthrocare Corp.	2007	—
+5	K071963	Modification 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	2	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

FIG. 1 — Lineage of K030551, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K020557	Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands	Arthrocare Corp.	2002	—

Also cleared against K020557: 4 other devices →

What descends from it? (52)

See all 52

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

Number	Device	Applicant	Decided	Descendants
K032504	Arthrocare System	Arthrocare Corp.	2003	51
K041810	Serfas Energy System	Stryker Endoscopy	2004	17
K173741	Reprocessed ArthoCare Ablation Wand	Renovo, Inc.	2018	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 5, 2008	Not classified	Z-1900-2009	Package design/selection	Potential Sterility Loss-- Due to wearing or puncture in the Tyvek lid, the product may lose sterility.

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.
None of the 4 ancestors has a recall.
Of its descendants, K032504 (Arthrocare Corp., 2003) has gone furthest, with 51 descendants of its own.
4 other devices also cite its predicate K020557.

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

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

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

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

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 ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030551 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030551: Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot Control; Power Cord; Wands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030551

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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