Pulse Oximetry Module

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

510(k) Number

K901071 ↗

FDA Product Code

DQA

Device Class

Class II

Regulation

21 CFR Part 870.2700

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

• 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

• Cd Telemetry Systems

  Class II

  FDA 510(k) K891104 Active Cleared 19 Apr 1989

See all devices from Marquette Electronics, Inc. →

• What clinical applications is this pulse oximetry module primarily used for in a hospital setting?

  This device is designed for non-invasive monitoring of arterial oxygen saturation (SpO₂) and pulse rate, making it suitable for cardiovascular monitoring and other clinical settings where real-time vital signs assessment is critical. Its FDA clearance under product code DQA reflects its intended use in environments requiring accurate, continuous tracking of oxygenation levels, such as intensive care units or post-operative recovery.

• Is this pulse oximetry module meant for single-use or can it be reused in a clinical environment?

  The device is explicitly labeled for single-use or reusable applications, meaning it can be used multiple times if properly cleaned and maintained according to manufacturer guidelines. The lack of sterility specifications in the regulatory data implies reuse is permitted under appropriate infection control protocols, though clinicians should follow Marquette Electronics’ instructions for reprocessing.

• How is this device supplied, and what should I consider when ordering?

  The Pulse Oximetry Module is supplied as a standalone module, meaning it is not part of a larger system but functions independently for measuring SpO₂ and pulse rate. When ordering, confirm whether you need single-use sensors (disposable) or a reusable module—though the module itself may be reusable, the sensors or probes may require replacement after each use depending on clinical practice. Check compatibility with your existing monitoring systems if integration is a concern.

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

  This device received FDA clearance through a Traditional 510(k) pathway (K901071) under product code DQA, classified as Class II with special controls. The