# DXN: System, Measurement, Blood-Pressure, Non-Invasive

- Device class: 2; regulation: 21 CFR 870.1130; FDA's rule: 510(k) required
- FDA decisions: 1,226
- 510(k) review time 2021–2025: median 157 days (middle half 115–222)
- Recalls: 20 (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: 33
- 2018: 22
- 2019: 33
- 2020: 24
- 2021: 23
- 2022: 25
- 2023: 35
- 2024: 17
- 2025: 28
- 2026: 29

## Most-cited predicates
- K051106: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors (2005), cited by 25
- K043217: A&D Medical UA-767PBT Digital Blood Pressure Monitor (2005), cited by 12
- K070826: KD-795 Wrist Measurement Electronic Blood Pressure Monitor (2007), cited by 9
- K160552: EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform (2016), cited by 9
- K040086: Health Buddy with Buddylink (2004), cited by 9
- K042273: Modification to Health Buddy with Device Connectivity (2004), cited by 9
- K042505: Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N (2005), cited by 7
- K061822: Omron Automatic Blood Pressure Monitor with Comfit Cuff, Model Hem 780 N3 (2006), cited by 7
- K013434: VP-2000/1000 (2002), cited by 7
- K003004: Oscar 2, Model 222 (2000), cited by 7

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