510(k) Report

510(k) · Cleared

Cleared

Arthrocare Bipolar Loop Electrode System

K955531510(k) TraditionalCleared Feb 21, 199679-day reviewClass II21 CFR 876.4300

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

Arthrocare Corp. · FAS Electrode, Electrosurgical, Active, Urological

Cleared on Feb 21, 1996 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1,329 later devices descend from it.

Decided
Feb 21, 1996
Review
79 days
Class
Class II
Product code
FAS
Recalls
None
Predicates
0

1,329 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared2002: 15 descendants cleared1996: 2 descendants cleared2001: 5 descendants cleared2003: 25 descendants cleared2006: 18 descendants cleared1998: 4 descendants cleared2000: 2 descendants cleared1999: 3 descendants cleared2004: 16 descendants cleared2005: 20 descendants cleared2010: 40 descendants cleared2007: 21 descendants cleared2013: 47 descendants cleared2008: 44 descendants cleared2016: 73 descendants cleared2015: 56 descendants cleared2019: 49 descendants cleared2025: 136 descendants cleared2009: 31 descendants cleared2012: 35 descendants cleared2014: 48 descendants cleared2022: 85 descendants cleared2024: 101 descendants cleared2023: 81 descendants cleared2011: 28 descendants cleared2018: 59 descendants cleared2021: 68 descendants cleared2020: 62 descendants cleared2017: 69 descendants cleared2026: 84 descendants cleared1995200020052010201520202025
  1. This deviceK955531 Arthrocare Bipolar Loop Electrode SystemArthrocare Corp. · 1996
  2. Descendant · cites it directly · 1,326 of its ownK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. Descendant · cites it directly · 1,325 of its ownK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. Descendant · cites it directly · 1,322 of its ownK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. Descendant · 2 generations on · 1,219 of its ownK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. Descendant · 2 generations on · 1,073 of its ownK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998

Showing 5 of 1,329 descendants. See all descendants

Descendants cleared per year

1996: 21997: 21998: 41999: 32000: 22001: 52002: 152003: 252004: 162005: 202006: 182007: 212008: 442009: 312010: 402011: 282012: 352013: 472014: 482015: 562016: 732017: 692018: 592019: 492020: 622021: 682022: 852023: 812024: 1012025: 1362026: 84
1996high 136 (2025) · low 2 (1996)2026

Most influential descendants

Showing 5 of 1,329 · See all
  • K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996 · cites it directly1,326descendants
  • K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996 · cites it directly1,325descendants
  • K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997 · cites it directly1,322descendants
  • K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998 · 2 generations on1,219descendants
  • K981870Visage Cosmetic Surgery SystemArthrocare Corp. · 1998 · 2 generations on1,073descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K955531Arthrocare Bipolar Loop Electrode SystemArthrocare Corp.1996—
+1K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
+1K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
+1K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
+2K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
+2K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199720
199840
199930
200020
200150
2002150
2003250
2004160
2005200
2006180
2007210
2008440
2009310
2010400
2011280
2012350
2013470
2014480
2015560
2016730
2017690
2018590
2019490
2020620
2021680
2022850
2023810
20241010
20251360
2026840
FIG. 1 — Lineage of K955531, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 FAS? 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 FAS device

  1. #1 K250522 Multi4 Systemscore 11.4 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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? (1,329)

See all 1,329

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

NumberDeviceApplicantDecidedDescendants
K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.19961,326
K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.19961,325
K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.19971,322
K971532Arthrocare Electrosurgery SystemArthrocare Corp.19971,029
K022543Arthrocare Bipolar Electrosurgery SystemArthrocare Corp.20021
K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp.20011
K031029Arthrocare Bipolar Electrosurgery SystemArthrocare Corp.20030

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, K961069 (Arthrocare Corp., 1996) has gone furthest, with 1,326 descendants of its own.

How does its category compare?

All FAS devices

FAS Electrode, Electrosurgical, Active, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FAS

2in 2025

2010: 32011: 12012: 22015: 12016: 12017: 22021: 22022: 12024: 12025: 2
2007high 3 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FAS

150in 2010

2010: 150 days median
2007high 150 (2010)2026

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

Recalls per year · FAS

1in 2023

2016: 22021: 42023: 1
2007high 4 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FAS

395in 2025

2007: 62008: 132009: 92010: 252011: 332012: 302013: 482014: 522015: 822016: 692017: 1212018: 702019: 612020: 1002021: 1022022: 1472023: 3292024: 3102025: 395
2007high 395 (2025) · low 6 (2007)2025

MAUDE reports naming product code FAS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—06
20080—013
20090—09
20103150025
20111—033
20122—030
20130—048
20140—052
20151—082
20161—269
20172—0121
20180—070
20190—061
20200—0100
20212—4102
20221—0147
20230—1329
20241—0310
20252—0395
20260—0—

More from Arthrocare Corp.

112 FDA decisions under this applicant name. See the company

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  • K130196Speedlock Knotless Fixation Device, 3MM Drill, 3MM+ Drill, Pathfinder Obturator & Sharp Tipped Obturator…Arthrocare Corp. · 2013
  • K111399Speedfix Suture Implant, 3.0MM Drill, Pathfinder Obturator, Sharp Tipped Obtrurator, Low Profile Drill Guide…Arthrocare Corp. · 2011
  • K111397Titan TI Suture Anchor SystemArthrocare Corp. · 2011

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https://510kreport.com/device/K955531 · printed Nov 6, 2026

Cite this page

510(k) Report. “K955531: Arthrocare Bipolar Loop Electrode System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955531

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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