IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)— 510(k) K252726
Substantially EquivalentPhilips Medizin Systeme Boeblingen GmbH
FDA 510(k) clearance K252726 for IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036), Substantially Equivalent on 2026-02-06. Applicant: Philips Medizin Systeme Boeblingen GmbH. Device class: 2.
Summary
Philips Medizin Systeme Boeblingen lists three IntelliVue items: the Multi-Measurement Module X3 (867030), the Patient Monitor MX100 (867033), and the MMX (867036). They're filed under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)). The record doesn't describe them beyond those names.
Class II, 21 CFR 870.1025. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Philips Medizin Systeme Boeblingen filed from Böblingen, Germany. The decision came 162 calendar days after FDA received it (August 28, 2025 to February 6, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Philips Medizin Systeme Boeblingen GmbH
- Product code
- Product code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Böblingen, DE
Recent devices under product code MHX
view allMore clearances from Philips Medizin Systeme Boeblingen GmbH
view all- K251146 — IntelliVue Patient monitors MX400, MX450, MX500, MX550
- K233440 — Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)
- K231671 — IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)
- K230604 — IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)
- K223574 — IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)
Adverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.