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SPM-300 Spirometer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K130322

by Bionet Co., Ltd.

Identifiers

510(k) Number
K130322 FDA 510(k)
FDA Product Code
BZG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1840 FDA 510(k)
Regulation Number
868.1840 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SPM-300 is a diagnostic spirometer designed to measure lung function parameters, including forced expiratory volume and vital capacity. It is classified as a Class II medical device and used for assessing respiratory health in clinical settings.

This device operates with disposable sensors, eliminating the need for disinfection between uses. Supplied as a reusable diagnostic tool, it is intended for use in general practice, specialty physician offices, and hospitals. The SPM-300 holds an FDA 510(k) clearance under the Anesthesiology advisory committee and adheres to regulation 868.1840.

Frequently asked questions

What clinical settings is the SPM-300 intended for use in and why does it stand out in those environments?

The SPM-300 is designed for use in general practice clinics, specialty physician offices, and hospitals. It stands out in these settings because it is a reusable diagnostic spirometer that eliminates the need for disinfection between uses, thanks to its disposable sensors. This feature reduces operational complexity and time spent on cleaning, making it practical for busy clinical environments where respiratory health assessments are frequently conducted.

How does the SPM-300 ensure patient safety and ease of use in a clinical workflow?

The SPM-300 ensures patient safety and workflow efficiency by using disposable sensors, which eliminates the risk of cross-contamination between patients. This design simplifies the clinical workflow, as there’s no need for manual disinfection or sterilization of reusable parts, allowing for quicker and more reliable lung function measurements. The device is reusable itself, making it cost-effective for long-term use in various healthcare settings.

What regulatory pathway was followed for the SPM-300, and what does this mean for healthcare providers?

The SPM-300 followed the FDA’s 510(k) clearance pathway under the Anesthesiology advisory committee, with a decision code of SESE (Substantially Equivalent). This means the device was determined to be as safe and effective as a legally marketed predicate device, adhering to regulation 868.1840. For healthcare providers, this indicates that the SPM-300 meets FDA standards for diagnostic spirometers, ensuring its reliability and compliance with regulatory requirements for use in clinical settings.

Are there different models or sizes available for the SPM-300, and how might this affect its application?

The provided data does not specify distinct models or sizes for the SPM-300, but it is classified as a Class II diagnostic spirometer with a broad range of registration numbers under the product code BZG. This suggests it is likely designed to meet general clinical needs for lung function testing, including forced expiratory volume and vital capacity measurements. While no variations are explicitly detailed, its reusable nature and disposable sensor system make it adaptable for various patient populations in different healthcare settings.

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: SPM-300 - Spirometer Sensor - Bionet America, SPM-300 by BIONET CO., LTD. | FDA 510 (k) Summary, Bionet SPM-300 Owner's Manual | Manualzz

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bionet Co., Ltd.

Sources (1)

  • FDA 510(k) K130322 24 fields · synced Sep 19, 2026