Disposable SpO2 Sensor

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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

Trade Name

Disposable Spo2 sensors EUDAMED

Sino-K GUDID

Generic Name

Pulse oximeter probe, single-use

Model / Reference

SP1019, 07-10-05

FDA applicant

Shenzhen Sino-K Medical Technology Co.,Ltd

Primary DI / UDI-DI

06972820960656

Basic UDI-DI

B-06972820960656

510(k) Number

K192608 ↗

FDA Product Code

DQA

EMDN Code

C900301 Pulse oximeter sensors

GMDN Term

Pulse oximeter probe, single-use

Device Class

Class IIb EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 870.2700

EU market of registration

Ireland

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• IBP Cable

  Class I

  CE/MDD

• SB0423

  Class I

  CE/MDD

• Sino-K SC0103

  Class II

  GUDID on market

• Sino-K SC0110

  Class II

  GUDID on market

• Sino-K SK11XXB

  Class II

  GUDID on market

• Sino-K SP1003

  Class II

  GUDID on market

See all devices from Shenzhen SINO-K Medical Technology Co., Ltd →

• What clinical setting is this disposable SpO₂ sensor designed for, and how does its single-use nature benefit patients and staff?

  The Disposable SpO₂ Sensor is designed for clinical settings where non-invasive, real-time monitoring of arterial blood oxygen saturation (SpO₂) is required, such as hospitals, emergency rooms, or surgical suites. Its single-use design ensures sterility and hygiene compliance, reducing the risk of cross-contamination between patients. This also eliminates the need for cleaning or reprocessing, which can be time-consuming and may introduce errors, while improving patient safety by preventing potential infections from reusable sensors.

• How is the sensor supplied, and what should clinicians check before using it to ensure proper functionality?

  The sensor is supplied in sterile packaging, which maintains its single-use integrity. Clinicians should verify that the packaging is intact and unopened before use to confirm sterility. Since it is designed for compatibility with standard pulse oximeters, they should also ensure the chosen device supports disposable sensors and that the sensor is correctly attached to the patient’s finger or earlobe following manufacturer instructions for optimal SpO₂ readings.

• Are there different sizes or models available for this sensor, and if so, how would a clinician determine the right fit for a patient?

  The provided specifications do not detail specific sizes or models beyond its classification as a disposable pulse oximetry sensor. However, most disposable SpO₂ sensors are designed with a universal adhesive strip to fit standard finger or earlobe sizes for adults and pediatric patients. Clinicians should refer to the manufacturer’s instructions for sizing guidance, ensuring the sensor adheres securely without excessive pressure, which could affect accuracy or patient comfort.

• What regulatory pathways does this device follow, and how does that impact its use in clinical practice?

  This sensor follows FDA 510(k) clearance and MDD (Medical Device Directive) compliance, indicating it has undergone regulatory review to demonstrate substantial equivalence to existing devices in the market. Clinicians can rely on these approvals to confirm the sensor meets safety and performance standards for clinical use. The FDA’s Cardiovascular advisory committee reviewed it under product code DQA, which aligns with pulse oximetry devices, ensuring its suitability for oxygen saturation monitoring in regulated healthcare environments.