510(k) Report

510(k) · Cleared

Cleared

Arthrocare Arthroscopic Electrosurgery System Model 970

K943450510(k) TraditionalCleared Mar 13, 1995238-day reviewClass II21 CFR 888.1100

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

Arthrocare Corp. · HRX Arthroscope

Cleared on Mar 13, 1995 after a 238-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1,334 later devices descend from it.

Decided
Mar 13, 1995
Review
238 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
0

1,334 later devices descend from it, 11 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared2000: 3 descendants cleared1996: 5 descendants cleared1999: 4 descendants cleared2001: 5 descendants cleared1998: 4 descendants cleared2006: 18 descendants cleared2002: 15 descendants cleared2003: 25 descendants cleared2010: 40 descendants cleared2004: 16 descendants cleared2005: 20 descendants cleared2016: 73 descendants cleared2015: 56 descendants cleared2013: 47 descendants cleared2007: 21 descendants cleared2019: 49 descendants cleared2025: 136 descendants cleared2012: 35 descendants cleared2008: 44 descendants cleared2022: 85 descendants cleared2009: 31 descendants cleared2014: 48 descendants cleared2011: 28 descendants cleared2018: 59 descendants cleared2021: 68 descendants cleared2020: 62 descendants cleared2024: 101 descendants cleared2023: 81 descendants cleared2017: 69 descendants cleared2026: 84 descendants cleared1995200020052010201520202025
  1. This deviceK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. Descendant · cites it directly · 1,327 of its ownK962321 Arthocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1996
  3. Descendant · cites it directly · 1,326 of its ownK961747 Arthrocare Arthroscopic Electrosurgery System (Model 970)Arthrocare Corp. · 1996
  4. Descendant · cites it directly · 1,326 of its ownK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  5. Descendant · cites it directly · 1,325 of its ownK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  6. Descendant · cites it directly · 1,324 of its ownK963123 Arthrocare Arthroscopic Eletrosurgery System (Model 980)Arthrocare Corp. · 1996

Showing 5 of 1,334 descendants. See all descendants

Descendants cleared per year

1996: 51997: 21998: 41999: 42000: 32001: 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 (1997)2026

Most influential descendants

Showing 5 of 1,334 · See all
  • K962321Arthocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1996 · cites it directly1,327descendants
  • K961747Arthrocare Arthroscopic Electrosurgery System (Model 970)Arthrocare Corp. · 1996 · cites it directly1,326descendants
  • K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996 · cites it directly1,326descendants
  • K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996 · cites it directly1,325descendants
  • K963123Arthrocare Arthroscopic Eletrosurgery System (Model 980)Arthrocare Corp. · 1996 · cites it directly1,324descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
+1K962321Arthocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1996—
+1K961747Arthrocare Arthroscopic Electrosurgery System (Model 970)Arthrocare Corp.1996—
+1K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
+1K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
+1K963123Arthrocare Arthroscopic Eletrosurgery System (Model 980)Arthrocare Corp.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199650
199720
199840
199940
200030
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 K943450, 1995–2026Source: 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 HRX? 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 HRX device

  1. #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 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? (1,334)

See all 1,334

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

NumberDeviceApplicantDecidedDescendants
K962321Arthocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.19961,327
K961747Arthrocare Arthroscopic Electrosurgery System (Model 970)Arthrocare Corp.19961,326
K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.19961,326
K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.19961,325
K963123Arthrocare Arthroscopic Eletrosurgery System (Model 980)Arthrocare Corp.19961,324
K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.19971,322
K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.19981,219
K971532Arthrocare Electrosurgery SystemArthrocare Corp.19971,029
K992581Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands, Orthowands…Arthrocare Corp.199923
K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp.20011

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, K962321 (Arthrocare Corp., 1996) has gone furthest, with 1,327 descendants of its own.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRX

9in 2025

2007: 72008: 92009: 112010: 92011: 32012: 112013: 122014: 92015: 42016: 82017: 42018: 122019: 122020: 72021: 72022: 32023: 42024: 62025: 92026 (partial year): 7
2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007: 89 days median2008: 115 days median2009: 139 days median2010: 114 days median2011: 84 days median2012: 102 days median2013: 90 days median2014: 140 days median2015: 132 days median2016: 89 days median2017: 97 days median2018: 101 days median2019: 45 days median2020: 141 days median2021: 57 days median2022: 89 days median2023: 249 days median2024: 110 days median2025: 107 days median2026 (partial year): 217 days median
2007high 249 (2023) · low 45 (2019)2026

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

Recalls per year · HRX

1in 2024

2007: 32008: 132009: 232010: 122011: 62013: 42015: 72018: 12021: 32024: 1
2007high 23 (2009) · low 0 (2012)2026

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

Adverse event reports per year · HRX

2,076in 2025

2007: 4212008: 4412009: 5582010: 6122011: 6312012: 7782013: 6782014: 8022015: 7632016: 4692017: 9342018: 1,5812019: 1,6762020: 1,7062021: 1,9082022: 1,4062023: 1,8522024: 2,4272025: 2,076
2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, 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
20077893421
2008911513441
20091113923558
2010911412612
20113846631
2012111020778
201312904678
201491400802
201541327763
20168890469
20174970934
20181210111,581
2019124501,676
2020714101,706
202175731,908
202238901,406
2023424901,852
2024611012,427
2025910702,076
202672170—

More from Arthrocare Corp.

112 FDA decisions under this applicant name. See the company

  • K153186Adjustable Fixation DeviceArthrocare Corp. · 2016
  • K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp. · 2013
  • 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

Recent decisions in HRX

The HRX category page

  • K263208Vantage Lumbar Decompression KitSurGenTec, LLC · 2026
  • K260156TruVision Single-Use 1.9mm Arthroscopy SystemNexus CMF, LLC · 2026
  • K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd. · 2026
  • K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KG · 2026
  • K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLC · 2026

https://510kreport.com/device/K943450 · printed Nov 5, 2026

Cite this page

510(k) Report. “K943450: Arthrocare Arthroscopic Electrosurgery System Model 970.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K943450

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026