# MXK: Device, Analysis, Anterior Segment

- Device class: 2; regulation: 21 CFR 886.1850; FDA's rule: 510(k) required
- FDA decisions: 23
- 510(k) review time 2021–2025: median 276 days (middle half 258–287)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2015: 1
- 2016: 1
- 2019: 2
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 1
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K030719: Pentacam Scheimpflug Camera (2003), cited by 5
- K152311: Pentacam AXL (2016), cited by 3
- K030393: Optical Low Coherence Reflectometry (Olcr) Pachymeter (2003), cited by 2
- K051940: CM 3910 Rotating Double Scheimpflug Camera (2005), cited by 2
- K991284: Anterior Eye-Segment Analysis System (1999), cited by 2
- K041841: Pachycam (2005), cited by 2
- K073508: Parkone (2008), cited by 1
- K984443: Orbscan (1999), cited by 1
- K150754: ARGOS (2015), cited by 1

Source page: https://510kreport.com/product-code/MXK
Data by year (CSV): https://510kreport.com/product-code/MXK.csv