Fingertip Pulse Oximeter
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K170965 FDA 510(k)
- FDA Product Code
- DQA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Fingertip Pulse Oximeter is a non-invasive medical device classified as a pulse oximeter (Device Type: DQA). It measures and displays the oxygen saturation of arterial blood (SpO₂) and pulse rate by transmitting light through a fingertip to detect hemoglobin oxygenation levels, providing real-time monitoring of a patient’s oxygenation status.
This device is intended for single-use or reusable application in clinical settings, including hospitals, emergency rooms, and outpatient care. Supplied sterile or non-sterile as specified, it adheres to FDA 510(k) clearance (K170965) and MDR compliance, with no MRI safety restrictions. It is available in standard sizes for adult and pediatric use, requiring proper storage as per manufacturer instructions to maintain accuracy and functionality.
Frequently asked questions
What clinical settings is this pulse oximeter designed for, and how does its single-use or reusable nature affect its use?
The Fingertip Pulse Oximeter is intended for use in clinical environments like hospitals, emergency rooms, and outpatient care. It is designed for single-use or reusable applications, meaning facilities can choose between disposable units (for cost-effective, infection-controlled use) or reusable models (for repeated use with proper cleaning and maintenance). The reusable option is ideal for high-volume settings where sterilization protocols can be strictly followed, while single-use models reduce cross-contamination risks in lower-volume or high-turnover areas.
Can this device be used on both adults and children, and if so, how are the sizes differentiated?
Yes, the Fingertip Pulse Oximeter is available in standard sizes for both adult and pediatric use, allowing for accurate measurements across different patient populations. The manufacturer likely designs the adult models with larger sensor tips for thicker fingers, while pediatric models feature smaller, more precise sensors to fit children’s fingertips comfortably. Always refer to the manufacturer’s instructions for proper probe selection based on patient age and finger size.
How should I store this device to ensure it remains accurate and functional over time?
Proper storage is critical to maintain the device’s accuracy and functionality. The manufacturer specifies that storage must follow their instructions to preserve performance, though exact details (e.g., temperature, humidity, or protection from light) aren’t provided here. Generally, pulse oximeters should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. For reusable models, ensure sensors are stored in a way that prevents damage or contamination before use.
Is this device compatible with MRI environments, and what regulatory pathways does it follow?
The Fingertip Pulse Oximeter has no MRI safety restrictions, meaning it can be used in non-MRI areas of hospitals without interference from magnetic fields. Regulatory-wise, it follows FDA 510(k) clearance (K170965) under the Special pathway, classified as substantially equivalent to predicate devices, and also complies with MDR (Medical Device Regulation) standards. This ensures it meets both U.S. and EU requirements for safety and performance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K170965 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Jumper Medical Equipment Co., Ltd.
Sources (2)
- FDA 510(k) K170965 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 29, 2026