INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550— 510(k) K131872

Clearance details

Applicant

Philips Medizinsysteme Boeblingen GmbH, Cardiac AN

Product code

Code MHX

Device class

Class 2

Regulation

21 CFR 870.1025

Advisory panel

Cardiovascular

Date received

2013-06-24

Decision date

2013-10-17

Decision

Substantially Equivalent

Clearance type

Special

Location

Boeblingen, Baden-Wuerttemberg, DE

• K260656 — Carescape ONE +6 more2026-09-01
• K260343 — Carescape Canvas 1000; Carescape Canvas Smart Display2026-08-28
• K260579 — Infinity® Acute Care System (IACS) VG8.12026-08-20
• K251508 — Telemetry Monitor (iT30, iT50)2026-08-06
• K253277 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P2026-07-24

• K141015 — INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT2014-05-19
• K132320 — INTELLIVUE CL RESPIRATION POD2014-03-26
• K131829 — INTELLIVUE PATIENT MONITOR2013-08-16
• K130849 — INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX4502013-06-14
• K120366 — INTELLIVUE PATIENT MONITOR2012-07-18

Death

580

Injury

2,441

Malfunction

12,655

Other

3

Total

15,679

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0864-2026 — IntelliVue Patient Monitor MX500. Product Number: 866064.Class II·Ongoing·Philips North America Llc·20251031
• Z-0865-2026 — IntelliVue Patient Monitor MX550. Product Number: 866066.Class II·Ongoing·Philips North America Llc·20251031
• Z-3249-2024 — IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066)Class II·Ongoing·Philips North America·20240830
• Z-0020-2025 — IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.Class II·Ongoing·Philips North America Llc·20230614
• Z-2328-2016 — IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.Class II·Terminated·Philips Electronics North America Corporation·20160726

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131872.