SPO2 Wrap Sensor

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K992211 ↗

FDA Product Code

DQA

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Epic SPO2 Finger Sensor, Model E412-20

  Class II

  FDA 510(k) K002223 Active Cleared 22 Aug 2000

• Stat-Shell Disposable SPO2 Sensor

  Class II

  FDA 510(k) K992092 Active Cleared 22 Dec 1999

• E100A Pulse Oximeter Finger Sensor/Probe

  Class II

  FDA 510(k) K954168 Active Cleared 12 Sep 1996

• Transducers for Ultrasound and Tocodynamometer Fetal Monitoring

  Class II

  FDA 510(k) K992811 Active Cleared 18 Jan 2000

• Flexi-Site (E203-01)/ Flexi-Fit (E300)

  Class II

  FDA 510(k) K964055 Active Cleared 21 Feb 1997

• Oximeter Pre-Amp Cable

  Class II

  FDA 510(k) K965172 Active Cleared 16 Jul 1997

See all devices from Epic Medical Equipment Services, Inc. →

• What is the SPO₂ Wrap Sensor used for?

  The SPO₂ Wrap Sensor is designed for non-invasive measurement of peripheral capillary oxygen saturation (SpO₂) in clinical settings. It attaches to extremities like fingers or toes and works with a fiberoptic oximeter catheter to provide continuous or intermittent monitoring of blood oxygen levels. This is particularly useful in areas such as operating rooms, intensive care units, or recovery areas where real-time SpO₂ tracking is critical for patient safety.

• How is the SPO₂ Wrap Sensor supplied and intended for use?

  The SPO₂ Wrap Sensor is supplied as a single-use, non-sterile medical device. It is intended for one-time clinical use only and should not be reused. The wrap-style design allows for easy attachment to extremities, ensuring accurate SpO₂ readings during monitoring. No special sterilization or preparation is required beyond standard single-use medical device handling.

• Does the SPO₂ Wrap Sensor require any special storage conditions?

  No special storage conditions are required for the SPO₂ Wrap Sensor beyond protecting it from physical damage and extreme temperatures. It should be stored in a clean, dry environment away from direct sunlight or moisture. Since it is single-use, ensure it remains unopened until use to maintain its intended performance and safety.

• Can the SPO₂ Wrap Sensor be used in MRI environments?

  The SPO₂ Wrap Sensor does not specify MRI safety information in its documentation. As a result, its use in MRI environments is not recommended unless explicitly verified by the manufacturer or through additional safety testing. Always confirm compatibility with MRI systems before use in such settings.

• What regulatory approval does the SPO₂ Wrap Sensor hold?

  The SPO₂ Wrap Sensor is authorized for use in the United States under FDA 510(k) clearance with the reference number K992211. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness. The device is classified under FDA Product Code DQA.