# MHX: Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

- Device class: 2; regulation: 21 CFR 870.1025; FDA's rule: 510(k) required
- FDA decisions: 431
- 510(k) review time 2021–2025: median 192 days (middle half 153–256)
- Recalls: 168 (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: 14
- 2018: 11
- 2019: 7
- 2020: 11
- 2021: 5
- 2022: 15
- 2023: 8
- 2024: 5
- 2025: 8
- 2026: 14

## Most-cited predicates
- K041235: Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors (2004), cited by 32
- K050762: Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90 (2005), cited by 31
- K030038: Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185 Opt C41 Wireless Bedside Adaptr (2003), cited by 29
- K040304: Philips Intellivue Patient Monitor, Models MP40 & MP50 (2004), cited by 29
- K040357: M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry Monitoring System II (2004), cited by 27
- K053522: Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00 (2006), cited by 25
- K062392: Philips MP5 Intellivue Patient Monitor (2006), cited by 25
- K052801: Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 (2005), cited by 23
- K063725: MP5 Intellivue Patient Monitor (2007), cited by 23
- K060541: The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors (2006), cited by 21

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