# OWN: Confocal Optical Imaging

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 63
- 510(k) review time 2021–2025: median 87 days (middle half 52–145)
- Recalls: 4 (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)
- 2017: 5
- 2018: 1
- 2019: 7
- 2020: 7
- 2021: 4
- 2022: 4
- 2023: 6
- 2024: 1
- 2025: 3
- 2026: 7

## Most-cited predicates
- K124031: DA Vinci Fluorescence Imaging Vision System (2013), cited by 6
- K142310: Stryker Infrared Fluorescence (IRF) Imaging System (2014), cited by 6
- K111047: Cellvizio 100 Series System with Confocal Miniprobes (2011), cited by 5
- K123676: Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes (2013), cited by 4
- K200737: SPY Portable Handheld Imaging (SPY-PHI) System (2020), cited by 4
- K231854: 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM (2023), cited by 4
- K172844: Cellvizio 100 Series System with Confocal Miniprobes (2017), cited by 3
- K212695: KARL STORZ ICG Imaging System (2021), cited by 3
- K210265: VS3 Iridium Sytem (2021), cited by 3
- K173866: Stryker AIM Light Source and SafeLight cable (2018), cited by 3

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