510(k) Report

510(k) · Cleared

Cleared

Hydrocision Arthrojet System with Cautery

K993009510(k) TraditionalCleared Oct 25, 199948-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

Hydrocision, Inc. · HRX Arthroscope

Cleared on Oct 25, 1999 as substantially equivalent to K982266 (Hydrocision, Inc., 1998) and 4 other predicates after a 48-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.

Decided
Oct 25, 1999
Review
48 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K943450 (1995). 9 ancestors in all, the oldest K791638 (1979). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1997: 1 other ancestor1986: 1 other ancestor1979: 1 other ancestor1996: 2 other ancestors2003: 1 descendant clearedK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961747 (1996), K963123 (1996) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 2 other ancestors 1 generation forward: 1 descendant K963123 · Arthrocare Arthroscopic Eletrosurgery System (Model 980) · Arthrocare Corp. · 1996K961747 · Arthrocare Arthroscopic Electrosurgery System (Model 970) · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 19950
  1. Root · 3 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 2 generations backK961747 Arthrocare Arthroscopic Electrosurgery System (Model 970)Arthrocare Corp. · 1996
  3. 1 generation backK963123 Arthrocare Arthroscopic Eletrosurgery System (Model 980)Arthrocare Corp. · 1996
  4. This deviceK993009 Hydrocision Arthrojet System with CauteryHydrocision, Inc. · 1999
  5. Descendant · cites it directly · 0 of its ownK031406 Exojet Tissue Management SystemMitek Worldwide · 2003

Most influential descendants

Showing 1 of 1 · See all
  • K031406Exojet Tissue Management SystemMitek Worldwide · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−2K961747Arthrocare Arthroscopic Electrosurgery System (Model 970)Arthrocare Corp.1996—
−1K963123Arthrocare Arthroscopic Eletrosurgery System (Model 980)Arthrocare Corp.1996—
0 (this device)K993009Hydrocision Arthrojet System with CauteryHydrocision, Inc.1999—
+1K031406Exojet Tissue Management SystemMitek Worldwide2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198610
199620
199710
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K993009, 1995–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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 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? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K982266Hydrocision Arthrojet System
Summary page 1
…HydroCision ArthroJet System with Cautery substantially equivalent in intended use and/or function to the following predicate devices: the HydroCision ArthroJet System (K982266) and the Valleylab ' Electrosurgical Pencil (K861112)/Valleylab Electrode (K791638), and the Kirwan Suction Coagulator (K965421).…
Hydrocision, Inc.1998—
*K861112Model E2517 and Model E2503 Power Control Pencils
Summary page 1
…lly equivalent in intended use and/or function to the following predicate devices: the HydroCision ArthroJet System (K982266) and the Valleylab ' Electrosurgical Pencil (K861112)/Valleylab Electrode (K791638), and the Kirwan Suction Coagulator (K965421). It is also substantially equivalent to the ArthroCar…
Valleylab, Inc.1986—
*K791638Model E2510 Surgiswitch
Summary page 1
…and/or function to the following predicate devices: the HydroCision ArthroJet System (K982266) and the Valleylab ' Electrosurgical Pencil (K861112)/Valleylab Electrode (K791638), and the Kirwan Suction Coagulator (K965421). It is also substantially equivalent to the ArthroCare Electrosurgery System (K9613…
Valleylab, Inc.1979—
*K965241Bipolar Suction Coagulator
Our OCR of the scanned summary read K965421, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Kirwan Suction Coagulator”.
Kirwan Surgical Products, Inc.1997—
*K963123Arthrocare Arthroscopic Eletrosurgery System (Model 980)
Our OCR of the scanned summary read K961323, FDA’s number for Lyofoam Extra C Odor Absorbing Wound Dressing (Acme United Corp.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “ArthroCare Electrosurgery System”.
Arthrocare Corp.1996—

Also cleared against K982266: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K031406Exojet Tissue Management SystemMitek Worldwide20030

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 4 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
  • None of the 9 ancestors has a recall.
  • Of its descendants, K031406 (Mitek Worldwide, 2003) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K982266.

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—

What is it indicated for?

The intended use of the HydroCision ArthroJet System with Cautery is to resect damaged tissue, remove extraneous matter, and control bleeding in surgical applications of articular body cavities.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K982266

3 other devices cite the same predicate.

  • K031406Exojet Tissue Management SystemMitek Worldwide · 2003
  • K012464Helix Hydro-JetAndreas Pein Medizintechnik GmbH · 2001
  • K991383Hydrocision Debdridement SystemHydrocision, Inc. · 2000

More from Hydrocision, Inc.

12 FDA decisions under this applicant name. See the company

  • K241990SpineSite Endoscope SystemHydrocision, Inc. · 2025
  • K200729HydroCision SpineJet SystemHydrocision, Inc. · 2020
  • K190804HydroCision TenJet DeviceHydrocision, Inc. · 2019
  • K041233Arthrojet XTHydrocision, Inc. · 2004
  • K032529Hydrocision Arthrojet System with Cautery, Turboburr and Curette, Models 51300, 51310Hydrocision, Inc. · 20032 recalls

Recent decisions in HRX

The HRX category page

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  • 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/K993009 · printed Nov 5, 2026

Cite this page

510(k) Report. “K993009: Hydrocision Arthrojet System with Cautery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993009

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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