510(k) · Cleared
ClearedMIDASVu
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intravu, Inc. · HRX Arthroscope
Cleared on Dec 2, 2024 as substantially equivalent to K181982 (Intravu, Inc., 2018) after a 66-day review. Its family tree reaches back 10 generations to 1983. 1 later device descends from it.
- Decided
- Dec 2, 2024
- Review
- 66 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K833587 (1983). 43 ancestors in all, the oldest K771218 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 6 generations between
- 3 generations backK141119 Camera Enabled ProbeTrice Medical, Inc. · 2014
- 2 generations backK162475 mi-eye 2, mi-eye 2 monitorTrice Medical · 2016
- 1 generation backK181982 MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc. · 2018
- This deviceK243020 MIDASVuIntravu, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK252579 Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 9 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
- 8 generations backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
- 7 generations backK043395 Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005
- 6 generations backK072879 Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · Recalled
- 5 generations backK082293 Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008
- 4 generations backK093717 C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010
- 3 generations backK141119 Camera Enabled ProbeTrice Medical, Inc. · 2014
- 2 generations backK162475 mi-eye 2, mi-eye 2 monitorTrice Medical · 2016
- 1 generation backK181982 MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc. · 2018
- This deviceK243020 MIDASVuIntravu, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K833587 | Disposable Arthroscopy Blade | Dyonics, Inc. | 1983 | — |
| −9 | K900070 | Modified Uses of the Arthroscopic Surgical System | Dyonics, Inc. | 1990 | — |
| −8 | K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | 1997 | — |
| −7 | K043395 | Smith & Nephew Videoarthroscope | Smith & Nephew, Inc. | 2005 | — |
| −6 | K072879 | Innervue Diagnostic Scope System | Biomet Orthopedics, Inc. | 2008 | 2 |
| −5 | K082293 | Surgview Integrated Visualization System | Biovision Technologies, LLC | 2008 | — |
| −4 | K093717 | C-Mor Visualization Device | Axis Surgical Technologies, Inc. | 2010 | — |
| −3 | K141119 | Camera Enabled Probe | Trice Medical, Inc. | 2014 | — |
| −2 | K162475 | mi-eye 2, mi-eye 2 monitor | Trice Medical | 2016 | — |
| −1 | K181982 | MIDAScope and Introducer Kit, and MIDASystem | Intravu, Inc. | 2018 | — |
| 0 (this device) | K243020 | MIDASVu | Intravu, Inc. | 2024 | — |
| +1 | K252579 | Orthoscan TAU MVP Mini C-Arm System | Ziehm-Orthoscan, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K181982 | MIDAScope and Introducer Kit, and MIDASystemSummary page 5…d Number: 21 CFR 888.1100 Device Classification: II Product Code: HRX Legally Marketed MIDAScope and Introducer Kit, and MIDASystem (K181982) Predicate Device: Product Code HRX, 21 CFR 888.1100 Description of the MIDASVu is an advanced imaging system compr… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252579 | Orthoscan TAU MVP Mini C-Arm System | 2026 | 0 |
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 41 years and passes through 8 companies; a new generation was cleared every 4.4 years on median.
- 3 of the 43 ancestors have a recall of any class.
- Of its descendants, K252579 (Ziehm-Orthoscan, Inc., 2026) has gone furthest, with 0 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. 2024, this device’s year, is highlighted.
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 MIDASVu is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of interior cavity joints and other body cavities through a natural or surgical opening.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243020: MIDASVu.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243020
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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