510(k) · Cleared
ClearedArthrex Continuous Wave Iii Arthoscopy Pump, Model AR-6475
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HRX Arthroscope
Cleared on Mar 20, 2003 after an 86-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Mar 20, 2003
- Review
- 86 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK024291 Arthrex Continuous Wave Iii Arthoscopy Pump, Model AR-6475Arthrex, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK083707 Arthrex Dual Wave Arthroscopy Fluid Management DeviceArthrex, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK180735 Endomat SelectKarl Storz SE & CO. KG · 2018
- Descendant · 3 generations on · 1 of its ownK201355 Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG · 2020
- Descendant · 4 generations on · 0 of its ownK261706 Endomat Select (UP220)Karl Storz SE & CO. KG · 2026
- Descendant · cites it directly · 0 of its ownK151932 Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use…Stryker Corporation · 2016
Most influential descendants
Showing 5 of 5 · See all- K083707Arthrex Dual Wave Arthroscopy Fluid Management DeviceArthrex, Inc. · 2009 · cites it directly3descendants
- K180735Endomat SelectKarl Storz SE & CO. KG · 2018 · 2 generations on2descendants
- K201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG · 2020 · 3 generations on1descendant
- K261706Endomat Select (UP220)Karl Storz SE & CO. KG · 2026 · 4 generations on0descendants
- K151932Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use TubingStryker Corporation · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K024291 | Arthrex Continuous Wave Iii Arthoscopy Pump, Model AR-6475 | Arthrex, Inc. | 2003 | — |
| +1 | K083707 | Arthrex Dual Wave Arthroscopy Fluid Management Device | Arthrex, Inc. | 2009 | — |
| +2 | K180735 | Endomat Select | Karl Storz SE & CO. KG | 2018 | — |
| +3 | K201355 | Endomat Select, IBS Shaver Software, License | Karl Storz SE & CO. KG | 2020 | — |
| +4 | K261706 | Endomat Select (UP220) | Karl Storz SE & CO. KG | 2026 | — |
| +1 | K151932 | Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing | Stryker Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | — | AR-6400 Arthrex arthroscopic pump Named without a submission number | |
| * | — | AR-6300 Arthrex arthroscopic pump Named without a submission number |
What descends from it? (5)
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, K083707 (Arthrex, Inc., 2009) has gone furthest, with 3 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 Arthrex Continuous Wave Ill Arthroscopy Pump is intended to provide
consistent, non-pulsing control of intra-articular irrigation and distention
pressuring during all phases of arthroscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024291: Arthrex Continuous Wave Iii Arthoscopy Pump, Model AR-6475.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024291
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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