510(k) · Cleared
ClearedHydrocision Arthrojet System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hydrocision, Inc. · HRX Arthroscope
Cleared on Sep 25, 1998 after an 88-day review. The FDA summary names its predicate without a number. 34 later devices descend from it.
- Decided
- Sep 25, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 0
34 later devices descend from it, 4 citing it directly.
- This deviceK982266 Hydrocision Arthrojet SystemHydrocision, Inc. · 1998
- Descendant · cites it directly · 31 of its ownK991383 Hydrocision Debdridement SystemHydrocision, Inc. · 2000
- Descendant · cites it directly · 19 of its ownK012464 Helix Hydro-JetAndreas Pein Medizintechnik GmbH · 2001
- Descendant · 2 generations on · 17 of its ownK022613 Helix Hydro-JetErbe USA, Inc. · 2002
- Descendant · 3 generations on · 16 of its ownK033590 Erbe Helix Hydro-JetErbe USA, Inc. · 2004
- Descendant · 2 generations on · 14 of its ownK072404 Erbe Erbejet 2 SystemErbe USA, Inc. · 2007
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K991383Hydrocision Debdridement SystemHydrocision, Inc. · 2000 · cites it directly31descendants
- K012464Helix Hydro-JetAndreas Pein Medizintechnik GmbH · 2001 · cites it directly19descendants
- K022613Helix Hydro-JetErbe USA, Inc. · 2002 · 2 generations on17descendants
- K033590Erbe Helix Hydro-JetErbe USA, Inc. · 2004 · 3 generations on16descendants
- K072404Erbe Erbejet 2 SystemErbe USA, Inc. · 2007 · 2 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982266 | Hydrocision Arthrojet System | Hydrocision, Inc. | 1998 | — |
| +1 | K991383 | Hydrocision Debdridement System | Hydrocision, Inc. | 2000 | — |
| +1 | K012464 | Helix Hydro-Jet | Andreas Pein Medizintechnik GmbH | 2001 | — |
| +2 | K022613 | Helix Hydro-Jet | Erbe USA, Inc. | 2002 | — |
| +3 | K033590 | Erbe Helix Hydro-Jet | Erbe USA, Inc. | 2004 | — |
| +2 | K072404 | Erbe Erbejet 2 System | Erbe USA, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 3 | 0 |
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 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? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Dyonics Articular Shaver System Named without a submission number |
What descends from it? (34)
See all 344 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, K991383 (Hydrocision, Inc., 2000) has gone furthest, with 31 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 | — |
What is it indicated for?
The ArthroJet system is intended to resect damaged tissue and remove extraneous matter found in articular body cavities. The system may be used open or arthroscopically to resect tears and other defects, remove loose fragments, shave away debris and perform appropriate synovectomy procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982266 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982266: Hydrocision Arthrojet System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982266
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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