Finger Pulse Oximeter X1906P
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221798 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 Finger Pulse Oximeter X1906P is a non-invasive medical device classified as an Oximeter (Product Code DQA), designed to measure and display oxygen saturation (SpO₂) and pulse rate in peripheral blood. It operates by emitting light through a finger probe to detect hemoglobin oxygenation levels, providing real-time monitoring of vital signs for clinical assessment.
This device is intended for single-use or reusable applications in clinical settings, including hospitals, outpatient care, and home monitoring environments. Supplied sterile or non-sterile as specified, it adheres to FDA 510(k) clearance (K221798) and MDD compliance, with no specific MRI safety restrictions noted. The device is regulated under Class II – Special Controls, with regulatory submissions filed under the Cardiovascular advisory committee.
Frequently asked questions
What clinical scenarios or environments is this pulse oximeter intended for, and how does its design support those uses?
The Finger Pulse Oximeter X1906P is designed for non-invasive monitoring of oxygen saturation (SpO₂) and pulse rate in clinical settings like hospitals, outpatient care, and home monitoring. Its finger probe emits light to measure hemoglobin oxygenation, enabling real-time vital sign tracking for patient assessment. The device’s single-use or reusable nature (depending on sterile/non-sterile supply) makes it versatile for both controlled clinical environments and patient self-monitoring at home, where portability and ease of use are critical.
How is the device supplied, and what does that mean for its usability in sterile versus non-sterile settings?
The Finger Pulse Oximeter X1906P is available in sterile or non-sterile configurations, allowing it to be used in both invasive and non-invasive clinical procedures. Sterile supply ensures compatibility with surgical or high-risk environments where contamination risks are minimized, while non-sterile versions are suitable for general outpatient or home monitoring where lower infection risks are acceptable. This flexibility accommodates diverse clinical workflows without requiring additional sterilization steps.
What are the key differences between the single-use and reusable versions of this device, and how should they be handled?
The device is intended for either single-use or reusable applications, though the specifics of reuse (e.g., cleaning protocols, maximum use cycles) are not detailed in the provided data. For single-use, the probe is discarded after one patient interaction, reducing cross-contamination risks. For reusable versions, proper disinfection and maintenance per manufacturer guidelines are essential to ensure accuracy and safety across multiple uses. The choice depends on infection control policies and resource availability in the clinical setting.
What regulatory pathways does this device follow, and how does that affect its availability or approval status?
The Finger Pulse Oximeter X1906P is cleared under FDA’s 510(k) pathway (K221798) as substantially equivalent to a predicate device, and it complies with the EU Medical Device Directive (MDD). This means it has undergone FDA review by the Cardiovascular Advisory Committee and is classified as Class II – Special Controls, indicating it meets stringent safety and performance standards. Availability is governed by these clearances, but the exact distribution channels (e.g., direct sales, distributors) would depend on regional compliance requirements and the manufacturer’s commercial strategy.
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. Sources consulted: Finger Pulse Oximeter, Model: X1906P (K221798) — FDA 510 (k ..., K221798 FDA 510 (k) - Finger Pulse Oximeter, Finger Pulse Oximeter, Model: X1906P 510(k) K221798 - FDA.report, Finger Pulse Oximeter, Model: X1906P (K221798) — FDA 510 (k ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K221798 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Changkun Technology Co., Ltd.
Sources (2)
- FDA 510(k) K221798 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 28, 2026