# DXJ: Display, Cathode-Ray Tube, Medical

- Device class: 2; regulation: 21 CFR 870.2450; FDA's rule: 510(k) required
- FDA decisions: 79
- 510(k) review time 2021–2025: median 106 days (middle half 92–121)
- Recalls: 17 (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)
- 2012: 1
- 2013: 3
- 2014: 4
- 2015: 2
- 2016: 1
- 2017: 4
- 2018: 4
- 2020: 1
- 2021: 2
- 2026: 1

## Most-cited predicates
- K100272: Intellivue Clinical Information Portfolio (2010), cited by 5
- K992636: HP Carevue 9000 Clinical Information System, Model M2331A (1999), cited by 5
- K083321: Cardio-View (2008), cited by 4
- K122167: Nexxis or (2013), cited by 3
- K013515: Infinity Explorer (2002), cited by 3
- K103473: Zoll Rescuenet Epcr Model Rescuenet Epcr (2011), cited by 3
- K180534: Philips IntelliVue GuardianSoftware (2018), cited by 2
- K173107: Vios Central Station Monitor Software, Vios Central Server Software (2018), cited by 2
- K945277: Hewlett-Packard Model M1490A Wireless Patient Data Communicator (1995), cited by 2
- K161767: Philips IntelliVue GuardianSoftware (2017), cited by 2

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