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Disposable SpO2 Sensors, Reusable SpO2 Sensors

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K181270

by Orantech Inc.

Identifiers

510(k) Number
K181270 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 Disposable SpO₂ Sensors and Reusable SpO₂ Sensors are pulse oximetry sensors designed to measure oxygen saturation (SpO₂) in arterial blood non-invasively. These devices clamp onto a finger, toe, or earlobe to detect oxygen levels by analyzing light absorption through the tissue, providing real-time monitoring of blood oxygenation.

These sensors are supplied as either single-use disposable units or reusable models, intended for use in clinical, home, or emergency settings. The disposable sensors are sterile and intended for one-time use, while the reusable sensors require cleaning and sterilisation between patients. Both variants comply with FDA 510(k) clearance under the traditional pathway and meet the requirements of the Medical Device Directive (MDD)

Frequently asked questions

What are the key differences between the disposable and reusable SpO₂ sensors from Orantech Inc.?

The disposable SpO₂ sensors are sterile and intended for single-use only, making them ideal for clinical or emergency settings where infection control is critical. In contrast, the reusable sensors require cleaning and sterilization between uses, which extends their lifespan but adds an extra step to their workflow. Both types measure oxygen saturation non-invasively by clamping onto a finger, toe, or earlobe, but the disposable version eliminates the need for reprocessing.

How are these SpO₂ sensors supplied, and what settings are they intended for?

The sensors are supplied as either disposable (sterile, single-use) or reusable (non-sterile, requiring reprocessing) units. They are designed for use in clinical environments, home monitoring, or emergency settings where real-time oxygen saturation measurement is needed. The choice between disposable and reusable depends on whether convenience, infection control, or cost efficiency is prioritized.

Do these sensors require any special storage conditions, and how should they be handled?

The disposable sensors should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain their sterility and functionality. The reusable sensors should be stored in a clean, dry place and handled with care to prevent damage before sterilization. Neither variant has specific storage temperature requirements mentioned, but standard medical device storage practices should be followed.

What regulatory pathways have these SpO₂ sensors undergone, and what does that mean for buyers?

These sensors have undergone FDA 510(k) clearance through the traditional pathway, meaning they were deemed substantially equivalent to a legally marketed device in the U.S. They also comply with the Medical Device Directive (MDD) in Europe. This regulatory clearance indicates that the sensors meet established safety and performance standards for non-invasive pulse oximetry, but buyers should verify local compliance requirements before use.

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

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Orantech Inc.
FDA Applicant
Orantech, Inc.

Sources (2)

  • FDA 510(k) K181270 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026