# MSX: System, Network And Communication, Physiological Monitors

- Device class: 2; regulation: 21 CFR 870.2300; FDA's rule: 510(k) required
- FDA decisions: 121
- 510(k) review time 2021–2025: median 221 days (middle half 173–295)
- Recalls: 19 (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: 2
- 2018: 4
- 2019: 4
- 2020: 5
- 2021: 3
- 2022: 5
- 2023: 3
- 2024: 4
- 2025: 4
- 2026: 5

## Most-cited predicates
- K042845: The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient Monitors (2004), cited by 29
- K191272: Wearable Device, Wearable Package (2019), cited by 5
- K103634: Ascom Clinicalconnex  Cardiomax (2011), cited by 4
- K193391: BeneVision Central Monitoring System (2020), cited by 4
- K102974: Intellisphere Event Managment System Rel. 10.00 (2011), cited by 4
- K971868: Impact (Informing Mobile Personnel and Care Tracking) Pager System (1997), cited by 3
- K080192: Hypervisor VI Central Monitoring System (Including TMS) (2008), cited by 3
- K210133: Current Health Monitoring System Gen 2 (G2) (2021), cited by 3
- K060254: Modification to Infinity Explorer (2006), cited by 3
- K132036: Hypervisor Central Monitoring System (Including Telemetry Monitoring System, TMS-6016) (2014), cited by 3

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