IntelliVue Patient Monitor— 510(k) K150310
Substantially EquivalentPhilips Medizin Systeme Boeblingen GmbH
FDA 510(k) clearance K150310 for IntelliVue Patient Monitor, Substantially Equivalent on 2015-05-13. Applicant: Philips Medizin Systeme Boeblingen GmbH. Device class: 2.
Clearance details
- Applicant
- Philips Medizin Systeme Boeblingen GmbH
- Product code
- Code DSI
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Boeblingen, DE
Recent devices under product code DSI
view allMore clearances from Philips Medizin Systeme Boeblingen GmbH
view all- K252726 — IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)
- 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)
Adverse events under product code DSI
product code DSI- Death
- 170
- Injury
- 729
- Malfunction
- 10,680
- Total
- 11,579
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 →
Recalls naming K150310
K-number listed on FDA's recall record- Z-0849-2026 — IntelliVue MP2. Product Number: M8102A.
- Z-0850-2026 — IntelliVue MP5. Product Number: M8105A.
- Z-0859-2026 — IntelliVue Multi Measurement Server X2. Product Number: M3002A.
- Z-0866-2026 — IntelliVue Patient Monitor MX600. Product Number: 865242.
- Z-0867-2026 — IntelliVue Patient Monitor MX700. Product Number: 865241.
- Z-0869-2026 — IntelliVue Patient Monitor MX800. Product Number: 865240.
- Z-2696-2020 — IntelliVue MX800 patient monitor, model no. 865240
- Z-2697-2020 — IntelliVue MX700 patient monitor, model no. 865241
- Z-0292-2018 — IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment.
- Z-0853-2016 — Philips IntelliVue Measurement Module X1 Model: M3001A
- Z-0854-2016 — Philips IntelliVue Module Measurement X2 Model: M3002A
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150310.
Data sourced from openFDA. This site is unofficial and independent of the FDA.