510(k) · Cleared
ClearedArthrocare Urology Electrosurgery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrocare Corp. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Mar 27, 2001 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 43 later devices descend from it.
- Decided
- Mar 27, 2001
- Review
- 29 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 0
43 later devices descend from it, 3 citing it directly.
- This deviceK010568 Arthrocare Urology Electrosurgery SystemArthrocare Corp. · 2001
- Descendant · cites it directly · 41 of its ownK011634 Arthrocare Controller, Model H2000; Arthrocare Cable, Model…Arthrocare Corp. · 2001
- Descendant · 2 generations on · 40 of its ownK020832 Arthrocare Controller, Arthrocare Cable, Foot Control, Power Cord…Arthrocare Corp. · 2002
- Descendant · 3 generations on · 24 of its ownK040338 Arthrocare Controller, Cable, Foot Control, Power Cord, Wands…Arthrocare Corp. · 2004
- 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 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K011634Arthrocare Controller, Model H2000; Arthrocare Cable, Model H0970-02; Footswitch, Model…Arthrocare Corp. · 2001 · cites it directly41descendants
- K020832Arthrocare Controller, Arthrocare Cable, Foot Control, Power Cord, WandsArthrocare Corp. · 2002 · 2 generations on40descendants
- K040338Arthrocare Controller, Cable, Foot Control, Power Cord, Wands, Models H0970-02…Arthrocare Corp. · 2004 · 3 generations on24descendants
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K010568 | Arthrocare Urology Electrosurgery System | Arthrocare Corp. | 2001 | — |
| +1 | K011634 | Arthrocare Controller, Model H2000; Arthrocare Cable, Model H0970-02… | Arthrocare Corp. | 2001 | — |
| +2 | K020832 | Arthrocare Controller, Arthrocare Cable, Foot Control, Power Cord, Wands | Arthrocare Corp. | 2002 | — |
| +3 | K040338 | Arthrocare Controller, Cable, Foot Control, Power Cord, Wands, Models… | Arthrocare Corp. | 2004 | — |
| +4 | K071963 | Modification to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| +5 | K072865 | Modificaton to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KNS? 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 KNS device
- #1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (43)
See all 433 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?
- Of its descendants, K011634 (Arthrocare Corp., 2001) has gone furthest, with 41 descendants of its own.
How does its category compare?
All KNS devicesKNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNS
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNS
14in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNS
1,504in 2025
MAUDE reports naming product code KNS, 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 | 1 | — | 3 | 164 |
| 2008 | 3 | 61 | 5 | 587 |
| 2009 | 3 | 212 | 2 | 1,027 |
| 2010 | 4 | 168 | 0 | 908 |
| 2011 | 1 | — | 2 | 860 |
| 2012 | 2 | — | 0 | 848 |
| 2013 | 2 | — | 0 | 449 |
| 2014 | 1 | — | 0 | 405 |
| 2015 | 3 | 252 | 0 | 406 |
| 2016 | 3 | 30 | 6 | 457 |
| 2017 | 3 | 48 | 1 | 446 |
| 2018 | 5 | 62 | 0 | 563 |
| 2019 | 7 | 66 | 0 | 668 |
| 2020 | 4 | 212 | 0 | 906 |
| 2021 | 4 | 139 | 41 | 814 |
| 2022 | 3 | 182 | 0 | 913 |
| 2023 | 9 | 83 | 0 | 976 |
| 2024 | 3 | 198 | 14 | 1,533 |
| 2025 | 11 | 171 | 0 | 1,504 |
| 2026 | 2 | — | 4 | — |
https://510kreport.com/device/K010568 · printed Nov 5, 2026
Cite this page
510(k) Report. “K010568: Arthrocare Urology Electrosurgery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K010568
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026