510(k) · Cleared
Clearedmi-eye 2, mi-eye 2 monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trice Medical · HRX Arthroscope
Cleared on Sep 16, 2016 as substantially equivalent to K141119 (Trice Medical, Inc., 2014) after a 10-day review. Its family tree reaches back 8 generations to 1983. 6 later devices descend from it.
- Decided
- Sep 16, 2016
- Review
- 10 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K833587 (1983). 25 ancestors in all, the oldest K771218 (1978). 6 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 7 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
- 6 generations backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
- 5 generations backK043395 Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005
- 4 generations backK072879 Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · Recalled
- 3 generations backK082293 Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008
- 2 generations backK093717 C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010
- 1 generation backK141119 Camera Enabled ProbeTrice Medical, Inc. · 2014
- This deviceK162475 mi-eye 2, mi-eye 2 monitorTrice Medical · 2016
- Descendant · cites it directly · 2 of its ownK181982 MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK243020 MIDASVuIntravu, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK252579 Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK233115 Hawkeye Control Unit with Eyas EndoscopeE Surgical, LLC · 2024
- Descendant · cites it directly · 0 of its ownK212556 mi-eye 3 needlescope with cannula, mi-tablet 3Trice Medical, Inc. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K181982MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc. · 2018 · cites it directly2descendants
- K243020MIDASVuIntravu, Inc. · 2024 · 2 generations on1descendant
- K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc. · 2026 · 3 generations on0descendants
- K233115Hawkeye Control Unit with Eyas EndoscopeE Surgical, LLC · 2024 · cites it directly0descendants
- K212556mi-eye 3 needlescope with cannula, mi-tablet 3Trice Medical, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K833587 | Disposable Arthroscopy Blade | Dyonics, Inc. | 1983 | — |
| −7 | K900070 | Modified Uses of the Arthroscopic Surgical System | Dyonics, Inc. | 1990 | — |
| −6 | K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | 1997 | — |
| −5 | K043395 | Smith & Nephew Videoarthroscope | Smith & Nephew, Inc. | 2005 | — |
| −4 | K072879 | Innervue Diagnostic Scope System | Biomet Orthopedics, Inc. | 2008 | 2 |
| −3 | K082293 | Surgview Integrated Visualization System | Biovision Technologies, LLC | 2008 | — |
| −2 | K093717 | C-Mor Visualization Device | Axis Surgical Technologies, Inc. | 2010 | — |
| −1 | K141119 | Camera Enabled Probe | Trice Medical, Inc. | 2014 | — |
| 0 (this device) | K162475 | mi-eye 2, mi-eye 2 monitor | Trice Medical | 2016 | — |
| +1 | K181982 | MIDAScope and Introducer Kit, and MIDASystem | Intravu, Inc. | 2018 | — |
| +2 | K243020 | MIDASVu | Intravu, Inc. | 2024 | — |
| +3 | K252579 | Orthoscan TAU MVP Mini C-Arm System | Ziehm-Orthoscan, Inc. | 2026 | — |
| +1 | K233115 | Hawkeye Control Unit with Eyas Endoscope | E Surgical, LLC | 2024 | — |
| +1 | K212556 | mi-eye 3 needlescope with cannula, mi-tablet 3 | Trice Medical, Inc. | 2021 | — |
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 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 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? (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 |
|---|---|---|---|
| * | K141119 | Camera Enabled ProbeSummary page 4…HRX, 888.1100 510(k) Number K162475 Predicate Device(s): The subject device is equivalent to the following devices: • K141119 – mi-eye Camera Enabled Probe Device Description: The Camera Enabled Probe is a battery operated, portable,… | 2014 |
What descends from it? (6)
4 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?
- The line of descent spans 33 years and passes through 7 companies; a new generation was cleared every 4.4 years on median.
- 2 of the 25 ancestors have a recall of any class.
- Of its descendants, K181982 (Intravu, Inc., 2018) has gone furthest, with 2 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. 2016, 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 mi-eye 2 is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162475 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162475: mi-eye 2, mi-eye 2 monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162475
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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