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Mediaid Disposable Non-Adhesive Sensors, Model Cst050-2101n +1 more model

FDA 510(k)

Class II (US FDA 510(k))

510(k) K061896

by Mediaid Inc

Identifiers

510(k) Number
K061896 FDA 510(k)
FDA Product Code
DQA FDA 510(k)
Models / Variants
Mediaid Disposable Non-Adhesive Sensors, Model Cst050-2101n FDA 510(k)
Reusable Finger Clip Sp02 Sensors, Model Cst060-2101n 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 Mediaid Disposable Non-Adhesive Sensors and Reusable Finger Clip SpO₂ Sensors are pulse oximetry sensors designed for non-invasive monitoring of arterial oxygen saturation (SpO₂) and pulse rate. These devices adhere to FDA’s classification as Class II medical devices, intended for continuous functional monitoring in clinical settings.

The disposable sensors (Model CST050-2101N) are single-use, non-adhesive, and intended for one-time application, while the reusable finger clip sensors (Model CST060-2101N) are designed for repeated use. Both models are cleared under FDA’s 510(k) pathway (K061896) and are supplied sterile for clinical use. They are intended for use in environments requiring non-invasive hemodynamic monitoring, such as hospitals, intensive care units, and procedural rooms.

Frequently asked questions

What is the primary clinical purpose of these pulse oximetry sensors, and where are they typically used?

These sensors are designed for non-invasive monitoring of arterial oxygen saturation (SpO₂) and pulse rate, enabling continuous functional assessment in clinical settings. They are specifically intended for use in environments like hospitals, intensive care units, and procedural rooms where real-time hemodynamic monitoring is required.

Are the disposable sensors reusable, and if not, how many times can the reusable sensors be used?

The disposable sensors (Model CST050-2101N) are explicitly labeled for single-use only, meaning they are intended for one-time application and should not be reused. In contrast, the reusable finger clip sensors (Model CST060-2101N) are engineered for repeated clinical use, though the exact number of uses isn’t specified—proper cleaning and maintenance per manufacturer guidelines are required.

How are these sensors supplied, and what does that mean for clinical workflows?

Both the disposable and reusable sensors are supplied sterile, ensuring they meet clinical hygiene standards out-of-the-box. The disposable model (CST050-2101N) is pre-packaged for one-time use, reducing preparation time, while the reusable model (CST060-2101N) requires post-use cleaning and sterilization before reuse, which may impact workflow efficiency but extends the sensor’s lifespan.

What regulatory pathway did these sensors follow to gain clearance, and what does that imply for their safety and performance?

These sensors were cleared through the FDA’s 510(k) pathway (K061896), specifically under the Traditional review process with a Substantially Equivalent (SESE) determination. This implies they were compared to a legally marketed predicate device and deemed to have the same intended use and technological characteristics, ensuring their safety and performance meet FDA standards for Class II medical devices.

Can you clarify the difference between the disposable and reusable sensor models in terms of application and clinical convenience?

The disposable sensors (CST050-2101N) are non-adhesive and designed for quick, one-time use without the need for adhesive removal, making them ideal for short-term or single-patient monitoring. The reusable finger clip sensors (CST060-2101N), however, are designed to be clipped onto a finger repeatedly, offering flexibility for prolonged or multi-patient use—though they require proper cleaning and sterilization between uses, which adds a step to clinical workflows.

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: Mediaid Disposable Non-adhesive Sensors, Model Cst050-2101n; Reusable ..., Mediaid Disposable Non-adhesive Sensors, Model Cst050-2101n; Reusable ..., Mediaid Disposable Non-adhesive Sensors, Model Cst050-2101n; Reusable ..., Mediaid Disposable Non-adhesive Sensors, Model Cst050-2101n; Reusable ..., Mediaid Disposable Non-adhesive Sensors, Model Cst050-2101n; Reusable ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mediaid Inc
FDA Applicant
Mediaid, Inc.

Sources (1)

  • FDA 510(k) K061896 24 fields · synced Sep 19, 2026