IntelliVue Patient Monitor— 510(k) K151681
Substantially EquivalentPhilips Medizin Systeme Boeblingen GmbH
FDA 510(k) clearance K151681 for IntelliVue Patient Monitor, Substantially Equivalent on 2015-07-17. 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 K151681
K-number listed on FDA's recall record- Z-0853-2026 — IntelliVue MP40. Product Number: M8003A.
- Z-0854-2026 — IntelliVue MP50. Product Number: M8004A.
- Z-0855-2026 — IntelliVue MP60. Product Number: M8005A.
- Z-0856-2026 — IntelliVue MP70. Product Number: M8007A.
- Z-0857-2026 — IntelliVue MP80. Product Number: M8008A.
- Z-0858-2026 — IntelliVue MP90. Product Number: M8010A.
- Z-0007-2025 — IntelliVue G7m Anesthesia Gas Module, Product Number 866173
- Z-2689-2020 — IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151681.
Data sourced from openFDA. This site is unofficial and independent of the FDA.