Vanguard Reprocessed Pulse Oximeter Sensors

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K042316 ↗

FDA Product Code

NLF

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Vanguard Reprocessed Non-Electric Biopsy Forceps

  Class I

  FDA 510(k) K042594 Active Cleared 25 Jan 2005

• Vanguard Reprocessed Femoral Compression Device

  Class II

  FDA 510(k) K011832 Active Cleared 21 Dec 2001

• Vanguard Reprocessed Diagnostic Electrophysiology Catheters

  Class II

  FDA 510(k) K042074 Active Cleared 9 Mar 2005

• Vanguard Reprocessed Compression Garment

  Class II

  FDA 510(k) K012403 Active Cleared 17 Oct 2001

• Reprocessed Disposable Cutters, Staplers and Appliers

  Class II

  FDA 510(k) K032973 Active Cleared 18 Dec 2003

• Vanguard Reprocessed Dilating Tip and Blunt Trocars

  Class II

  FDA 510(k) K043253 Active Cleared 8 Apr 2005

See all devices from Vanguard Medical Concepts, Inc. →

• What is the Vanguard Reprocessed Pulse Oximeter Sensor used for?

  The Vanguard Reprocessed Pulse Oximeter Sensor is used to measure oxygen saturation and pulse rate in patients. It functions by emitting red and infrared light through tissue and detecting transmitted light with a photosensor, typically applied to the finger, foot, or hand.

• How is the Vanguard Reprocessed Pulse Oximeter Sensor supplied and prepared for use?

  The device is supplied after being cleaned, reworked (including replacement of patient-contacting tape), inspected, tested, and sterilized by Vanguard Medical Concepts, Inc. It is intended for use by healthcare professionals in clinical settings.

• Is the Vanguard Reprocessed Pulse Oximeter Sensor designed for single-use or reuse?

  The Vanguard Reprocessed Pulse Oximeter Sensor is designed for reuse after reprocessing. It undergoes cleaning, rework, inspection, testing, and sterilization by the manufacturer to enable safe multiple patient use under regulatory authorization.