Oxisensor II Recycled Sensor and Oximax Recycled Sensor

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K033973 ↗

FDA Product Code

NLF

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Shiley Flextra Tracheostomy Tube

  Class II

  FDA 510(k) K030787 Active Cleared 14 Nov 2003

• Nellcor Symphony N-3000 Patient Monitor with SPO2 and ECG and N-3200 Display/Printer

  Class II

  FDA 510(k) K963400 Active Cleared 26 Nov 1996

• Npb-290 Pulse Oximeter (Npb-290)

  Class II

  FDA 510(k) K972837 Active Cleared 21 Oct 1997

• Nellcor Oximax Pulse Oximetry Sensons (Max-a, Max-Al, Max-N, Max-I, Max-P

  Class II

  FDA 510(k) K052186 Active Cleared 10 Nov 2005

• Nellcor Puritan Bennett Achieva Ventilator and Report Generator

  Class II

  FDA 510(k) K990177 Active Cleared 18 Nov 1999

• Nellcor N-200 Pulse Oximeter, Model N-200

  Class II

  FDA 510(k) K022819 Active Cleared 24 Sep 2002

See all devices from Nellcor Puritan Bennett, Inc. →

• What are the Oxisensor II Recycled Sensors used for?

  These sensors are designed for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in neonatal, pediatric, and adult patients when used with compatible pulse oximeter monitoring systems.

• Are these sensors single-use or reusable?

  The recycled sensors are supplied as single-use devices and are not intended for reuse. They are designed for one-time patient use to ensure accurate readings and maintain hygiene standards.

• What is the regulatory status of these sensors?

  The device has received FDA 510(k) clearance with product code NLF and is classified as a Class II medical device for cardiovascular use. This indicates it meets the FDA's safety and effectiveness requirements for its intended use.

• What patient populations can use these sensors?

  These sensors are designed to be used with neonatal, pediatric, and adult patients, making them versatile for various clinical settings where pulse oximetry monitoring is required across different age groups.