# K162475: mi-eye 2, mi-eye 2 monitor

- Pathway: 510(k) (Special)
- Applicant: Trice Medical
- Decided: Sep 16, 2016 after 10 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K833587 (1983). 25 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141119: Camera Enabled Probe, Trice Medical, Inc. (2014) Summary page 4.

## Most influential descendants
- K181982: MIDAScope and Introducer Kit, and MIDASystem (2018), 2 descendants of its own
- K243020: MIDASVu (2024), 1 descendant of its own
- K252579: Orthoscan TAU MVP Mini C-Arm System (2026), 0 descendants of its own
- K233115: Hawkeye Control Unit with Eyas Endoscope (2024), 0 descendants of its own
- K212556: mi-eye 3 needlescope with cannula, mi-tablet 3 (2021), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K162475
Methodology: https://510kreport.com/methodology