510(k) · Cleared
ClearedArthur
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ROPCA ApS · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jun 18, 2026 as substantially equivalent to K161354 (Adecho Tech, 2017) and 1 other predicate after a 147-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- Jun 18, 2026
- Review
- 147 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K922470 (1992). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- 6 generations backK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
- 5 generations backK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
- 4 generations backK052355 Automated Breast Ultrasound System, Model AbusU-Systems, Inc. · 2005
- 3 generations backK070477 Orison Embrace SystemOrison Corporation · 2007
- 2 generations backK082543 Sonocine Adjunctive Breast Ultrasound System (Abu), Model 100Sonocine, Inc. · 2008
- 1 generation backK161354 MELODY, Remote Control System for Ultrasound ProbeAdecho Tech · 2017
- This deviceK260190 ArthurROPCA ApS · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K922470 | Ies, Image Enhancement System | Open Mri, Inc. | 1992 | — |
| −6 | K993802 | Sharpview Image Enhancement System | Context Vision AB | 2000 | — |
| −5 | K024028 | Sharp View Image Enhancement System | Context Vision AB | 2003 | — |
| −4 | K052355 | Automated Breast Ultrasound System, Model Abus | U-Systems, Inc. | 2005 | — |
| −3 | K070477 | Orison Embrace System | Orison Corporation | 2007 | — |
| −2 | K082543 | Sonocine Adjunctive Breast Ultrasound System (Abu), Model 100 | Sonocine, Inc. | 2008 | — |
| −1 | K161354 | MELODY, Remote Control System for Ultrasound Probe | Adecho Tech | 2017 | — |
| 0 (this device) | K260190 | Arthur | ROPCA ApS | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2008 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K161354 | MELODY, Remote Control System for Ultrasound ProbeSummary page 5…uct Code(s) IYO, ITX, IYN, QIH | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K161354 MELODY, Remote Control System for Ultrasound Probe IYO K080555 Sofia Automated Tomographic Ultrasound (ATUS) ITX Device Descripti… | 2017 |
| * | K080555 | Sofia Automated Tomographic Ultrasound (Atus)Summary page 5…ices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K161354 MELODY, Remote Control System for Ultrasound Probe IYO K080555 Sofia Automated Tomographic Ultrasound (ATUS) ITX Device Description Summary 21 CFR 807.92(a)(4) ARTHUR stands for ARTHritis Ult… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 34 years and passes through 7 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 13 ancestors have a recall of any class.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
ARTHUR by ROPCA is intended to hold an external ultrasound transducer of cleared ultrasound equipment for automatic image capturing of finger and wrist joints.
ARTHUR is indicated for adult patients, that are under investigation or monitoring of musculoskeletal diseases.
The system shall be used in a professional healthcare facility environment.
ARTHURs mode of operation is to use B-mode (2D), Color Doppler and/or Power Doppler mode
on connected ultrasound machines.
The clinical application is musculoskeletal ultrasound of the hand and wrist joints.
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/K260190 · printed Nov 5, 2026
Cite this page
510(k) Report. “K260190: Arthur.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K260190
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026