Oxilink (Small, Medium, Large)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K953126 ↗

FDA Product Code

DQA

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Capnocheck II, Model 8400

  Class II

  FDA 510(k) K991086 Active Cleared 9 Jun 1999

• NEWOX2

  Class II

  FDA 510(k) K945754 Active Cleared 17 Jul 1995

• Autocorr Plus; 3404 Oximeter/ECG Monitor

  Class II

  FDA 510(k) K981939 Active Cleared 20 Aug 1998

• Pulse Oximeter

  Class II

  FDA 510(k) K941289 Active Cleared 22 Jun 1994

• 3301T Oxitemp

  Class II

  FDA 510(k) K946185 Active Cleared 17 Mar 1995

• BCI 3401 Handheld Pulse Oximeter

  Class II

  FDA 510(k) K980714 Active Cleared 25 Mar 1998

See all devices from Bci Intl., Inc. →

• What clinical settings is the Oxilink pulse oximeter designed for, and how does its size selection factor into its use?

  The Oxilink pulse oximeter is intended for use in clinical environments like hospitals, operating rooms, and emergency care settings. Its availability in Small, Medium, and Large sizes allows for flexibility in patient populations, including both adult and pediatric patients, ensuring proper fit and accurate monitoring of oxygen saturation (SpO₂) and pulse rate.

• Is the Oxilink pulse oximeter reusable, and if so, what guidelines should be followed for reuse?

  The Oxilink pulse oximeter is designed for single-use or reusable clinical settings, depending on manufacturer guidelines. If reuse is intended, the manufacturer’s specific cleaning, sterilization, and maintenance protocols must be strictly followed to ensure safety, performance, and compliance with regulatory standards.

• Does the Oxilink pulse oximeter require any special handling or storage conditions?

  While the provided data does not specify exact storage conditions, pulse oximeters like the Oxilink generally require protection from extreme temperatures, moisture, and direct sunlight. Since it is intended for clinical use, it should be stored in a clean, dry environment as per the manufacturer’s instructions to maintain accuracy and reliability.

• What regulatory pathway was followed for FDA clearance of the Oxilink pulse oximeter, and what does that mean for its safety standards?

  The Oxilink pulse oximeter received FDA clearance through a 510(k) Traditional pathway, specifically under K953126, and was determined to be substantially equivalent to a legally marketed predicate device. This means it meets FDA’s special controls for Class II cardiovascular-related monitoring devices, ensuring it adheres to established safety and performance standards for noninvasive pulse oximetry.