# NEZ: System, Imaging, Gastrointestinal, Wireless, Capsule

- Device class: 2; regulation: 21 CFR 876.1300; FDA's rule: 510(k) required
- FDA decisions: 47
- 510(k) review time 2021–2025: median 99 days (middle half 90–117)
- Recalls: 2 (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: 4
- 2018: 3
- 2019: 2
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 1
- 2024: 3
- 2025: 1
- 2026: 1

## Most-cited predicates
- DEN010002: Given Diagnostic Imaging System (2001), cited by 13
- K020341: Given Diagnostic System (2002), cited by 12
- K022362: Given Diagnostics System (2002), cited by 11
- K022980: Modification to Given Diagnostic System (2003), cited by 10
- K031033: Given Diagnostic System (2003), cited by 9
- K032405: Given Diagnostic System (2003), cited by 7
- K123864: Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule Endoscopy System (2013), cited by 6
- K040248: Modification to Given Diagnostic System (2004), cited by 6
- K070475: Modificaton to: Given Diagnostic Imaging System (2007), cited by 5
- K143663: MiroCam Capsule Endoscope System (2015), cited by 3

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