Marquette Ear Probe Sensor

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K942752 ↗

FDA Product Code

DPZ

Device Class

Class II

Regulation

21 CFR Part 870.2710

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Alarm Display Unit/Pager-Lan System (Adu)

  Class II

  FDA 510(k) K962827 Active Cleared 24 Feb 1997

• Marquette 1200 Defibrillator

  Class III

  FDA 510(k) K882067 Active Cleared 17 Nov 1988

• Pulse Oximetry Module

  Class II

  FDA 510(k) K901071 Active Cleared 19 Jun 1990

• Smart Anesthesia Multi-Gas (Sam) Module

  Class II

  FDA 510(k) K943977 Active Cleared 23 Mar 1995

• Cardiosoft/Cardiosys

  Not classified

  FDA 510(k) K951130 Active Cleared 4 Apr 1996

• Silver Mactrode

  Class II

  FDA 510(k) K902176 Active Cleared 4 Sep 1990

See all devices from Marquette Electronics, Inc. →

• What is the primary purpose of the Marquette Ear Probe Sensor and how does it function in clinical settings?

  The Marquette Ear Probe Sensor is a non-invasive ear oximeter designed to measure arterial blood oxygen saturation by transmitting light through the ear. It operates as an extravascular sensor, providing continuous or intermittent monitoring of oxygen levels for clinical assessment. This makes it useful in settings like hospitals and operating rooms where real-time oxygen level tracking is critical for patient care.

• Is the Marquette Ear Probe Sensor intended for single-use or reusable applications, and how should it be handled?

  The Marquette Ear Probe Sensor is explicitly designed as a reusable component, intended for use with compatible monitoring systems in clinical environments. Since it is reusable, proper cleaning, sterilization, and maintenance protocols must be followed to ensure accuracy and hygiene between uses, particularly in high-touch areas like hospitals and operating rooms.

• What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for its use?

  The Marquette Ear Probe Sensor received FDA clearance through a 510(k) pathway, specifically under the Traditional Review process, with a decision date of September 2, 1994. This clearance was granted under the Cardiovascular Advisory Committee (CV) and classified as a Class II medical device under regulation number 870.2710. The clearance confirms it meets FDA standards for safety and effectiveness as an ear oximeter for oxygen saturation monitoring, ensuring its use is compliant with U.S. medical device regulations.

• Are there different sizes or models of the Marquette Ear Probe Sensor, and how would I identify the correct one for my needs?

  The provided data does not specify distinct sizes or models beyond the core product name, the Marquette Ear Probe Sensor. However, the OpenFDA registration numbers (e.g., 3004415095, 3013557562) suggest multiple lot or batch identifiers may exist for inventory tracking. To ensure compatibility, verify the sensor’s product code (DPZ) and confirm it aligns with your monitoring system’s specifications. Contact Marquette Electronics, Inc. (100 Marquette Dr., Jupiter, FL 33468) for model-specific details or technical support.