510(k) · Cleared
ClearedMIDAScope and Introducer Kit, and MIDASystem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intravu, Inc. · HRX Arthroscope
Cleared on Aug 21, 2018 as substantially equivalent to K162475 (Trice Medical, 2016) and 1 other predicate after a 27-day review. Its family tree reaches back 9 generations to 1983. 2 later devices descend from it.
- Decided
- Aug 21, 2018
- Review
- 27 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K833587 (1983). 42 ancestors in all, the oldest K771218 (1978). 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 5 generations between
- 3 generations backK093717 C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010
- 2 generations backK141119 Camera Enabled ProbeTrice Medical, Inc. · 2014
- 1 generation backK162475 mi-eye 2, mi-eye 2 monitorTrice Medical · 2016
- This deviceK181982 MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK243020 MIDASVuIntravu, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK252579 Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 8 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
- 7 generations backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
- 6 generations backK043395 Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005
- 5 generations backK072879 Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · Recalled
- 4 generations backK082293 Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008
- 3 generations backK093717 C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010
- 2 generations backK141119 Camera Enabled ProbeTrice Medical, Inc. · 2014
- 1 generation backK162475 mi-eye 2, mi-eye 2 monitorTrice Medical · 2016
- This deviceK181982 MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K833587 | Disposable Arthroscopy Blade | Dyonics, Inc. | 1983 | — |
| −8 | K900070 | Modified Uses of the Arthroscopic Surgical System | Dyonics, Inc. | 1990 | — |
| −7 | K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | 1997 | — |
| −6 | K043395 | Smith & Nephew Videoarthroscope | Smith & Nephew, Inc. | 2005 | — |
| −5 | K072879 | Innervue Diagnostic Scope System | Biomet Orthopedics, Inc. | 2008 | 2 |
| −4 | K082293 | Surgview Integrated Visualization System | Biovision Technologies, LLC | 2008 | — |
| −3 | K093717 | C-Mor Visualization Device | Axis Surgical Technologies, Inc. | 2010 | — |
| −2 | K141119 | Camera Enabled Probe | Trice Medical, Inc. | 2014 | — |
| −1 | K162475 | mi-eye 2, mi-eye 2 monitor | Trice Medical | 2016 | — |
| 0 (this device) | K181982 | MIDAScope and Introducer Kit, and MIDASystem | Intravu, Inc. | 2018 | — |
| +1 | K243020 | MIDASVu | Intravu, Inc. | 2024 | — |
| +2 | 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 |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K162475 | mi-eye 2, mi-eye 2 monitorSummary page 4…Orthopedic Predicate Device 510(k) Number Product Name Manufacturer K162475 mi-eye 2 and mi-eye 2 Monitor (primary predicate) Trice Medical, Inc. K141326 NeedleView CH™ Scope Ki… | 2016 |
| * | K141326 | Needle View CH Scope KitsSummary page 4…Product Name Manufacturer K162475 mi-eye 2 and mi-eye 2 Monitor (primary predicate) Trice Medical, Inc. K141326 NeedleView CH™ Scope Kits BioVition Technologies, LLC K152511 Neo-Arthroscope… | 2014 |
| † | K152511 | Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243020 | MIDASVu | 2024 | 1 |
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 35 years and passes through 8 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 42 ancestors have a recall of any class.
- Of its descendants, K243020 (Intravu, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K162475.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 MIDAScope™ and Introducer Kit, and MIDASystem™ are 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/K181982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181982: MIDAScope and Introducer Kit, and MIDASystem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181982
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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