Nellcor Compatible Reusable Spo2 Soft-Finger Sensor, Model T100a-090103
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Reusable SpO2 sensors EUDAMED
- Device Name
- pulse oixmeter sensor ，Reusable EUDAMED
- Model / Reference
- S300P EUDAMEDS300P-090109 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06900234105028 EUDAMED
- Basic UDI-DI
- B-06900234105028 EUDAMED
- 510(k) Number
- K100077 FDA 510(k)
- FDA Product Code
- DQA FDA 510(k)
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
This device is a reusable soft-finger pulse oximetry sensor designed for compatibility with Nellcor-compatible patient monitors or pulse oximeters. It measures oxygen saturation (SpO₂) in adult or pediatric patients by attaching to a finger, providing non-invasive monitoring of blood oxygen levels.
The sensor is intended for reusable clinical use in hospital or home settings and is classified as a Class II medical device under FDA regulations. It requires proper cleaning and sterilization between uses, adhering to manufacturer guidelines for maintenance. Authorized for use in the United States via FDA 510(k) clearance (K100077) and compliant with the Medical Device Directive (MDD)
Frequently asked questions
Is this sensor designed for single-use or reusable in clinical settings, and what maintenance is required?
This sensor is explicitly designed for reusable clinical use in both hospital and home settings. Since it is reusable, it must be properly cleaned and sterilized between uses to ensure patient safety and device performance. The manufacturer provides specific guidelines for maintenance, which must be followed to comply with regulatory requirements and prevent cross-contamination.
What types of patients can use this pulse oximetry sensor, and how is it applied?
This soft-finger pulse oximetry sensor is designed for adult and pediatric patients to measure oxygen saturation (SpO₂) non-invasively. It is applied by attaching it to a finger, making it suitable for continuous monitoring in various clinical environments where accurate SpO₂ readings are needed.
What compatibility considerations should clinicians keep in mind when using this device?
This sensor is specifically designed for compatibility with Nellcor-compatible patient monitors or pulse oximeters, meaning it should only be used with devices that support this model (T100A-090103). Clinicians should verify that their existing equipment is compatible before use to ensure accurate and reliable oxygen saturation readings.
How is the regulatory status of this device determined, and where can I find more details?
This device holds FDA 510(k) clearance (K100077) under the Traditional clearance route, meaning it was determined to be substantially equivalent to a legally marketed predicate device. It is also compliant with the Medical Device Directive (MDD). For full regulatory details, including the clearance summary and submission history, you can reference the FDA’s device database using the K-number (K100077) or contact the manufacturer, Solaris Medical Technology, Inc.
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: Nellcor Compatible Reusable Spo2 Soft-finger Sensor, Model T100a-090103, PDF Nellcor Compatible Reusable Spo2 Soft-finger Sensor, Model T100a-090103 ..., Reusable Soft Silicon Finger Oximetry Sensor (Solaris) Paediatric or ..., Nellcor Compatible Reusable Spo2 Soft-finger Sensor, Model T100a-090103, Adult soft finger sensor 90cm Nellcor non Oximax (OEM Compatible ...
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 | K100077 | Class II | Active |
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Manufacturer
- Manufacturer
- Solaris Medical Technology, Inc.
Sources (2)
- FDA 510(k) K100077 24 fields · synced Sep 18, 2026
- EUDAMED 93895068-f4d7-4d5d-8ce8-cc143e629c11 61 fields · synced Jul 15, 2026