510(k) · Cleared
ClearedHydrocision Arthrojet System with Cautery and Burr
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hydrocision, Inc. · HRX Arthroscope
Cleared on Nov 24, 2000 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Nov 24, 2000
- Review
- 80 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK002764 Hydrocision Arthrojet System with Cautery and BurrHydrocision, Inc. · 2000
- Descendant · cites it directly · 8 of its ownK020688 Hydrocision Arthojet System with Cautery and TurboburrHydrocision, Inc. · 2002
- Descendant · 2 generations on · 6 of its ownK032529 Hydrocision Arthrojet System with Cautery, Turboburr and Curette…Hydrocision, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 5 of its ownK041233 Arthrojet XTHydrocision, Inc. · 2004
- Descendant · 4 generations on · 1 of its ownK122861 XTOOLOuroboros Medical · 2012
- Descendant · 5 generations on · 0 of its ownK213978 TELIGEN SystemMedos International SARL · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K020688Hydrocision Arthojet System with Cautery and TurboburrHydrocision, Inc. · 2002 · cites it directly8descendants
- K032529Hydrocision Arthrojet System with Cautery, Turboburr and Curette, Models 51300, 51310Hydrocision, Inc. · 2003 · 2 generations on6descendants
- K041233Arthrojet XTHydrocision, Inc. · 2004 · 3 generations on5descendants
- K122861XTOOLOuroboros Medical · 2012 · 4 generations on1descendant
- K213978TELIGEN SystemMedos International SARL · 2022 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002764 | Hydrocision Arthrojet System with Cautery and Burr | Hydrocision, Inc. | 2000 | — |
| +1 | K020688 | Hydrocision Arthojet System with Cautery and Turboburr | Hydrocision, Inc. | 2002 | — |
| +2 | K032529 | Hydrocision Arthrojet System with Cautery, Turboburr and Curette, Models… | Hydrocision, Inc. | 2003 | 2 |
| +3 | K041233 | Arthrojet XT | Hydrocision, Inc. | 2004 | — |
| +4 | K122861 | XTOOL | Ouroboros Medical | 2012 | — |
| +5 | K213978 | TELIGEN System | Medos International SARL | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 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 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 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? (9)
2 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, K020688 (Hydrocision, Inc., 2002) has gone furthest, with 8 descendants of its own.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
https://510kreport.com/device/K002764 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002764: Hydrocision Arthrojet System with Cautery and Burr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002764
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026