← Back to catalogue

MSA100BT Peak Flow Meter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K170281

by Beijing M&B Electronic Instruments Co., Ltd.

Identifiers

510(k) Number
K170281 FDA 510(k)
FDA Product Code
BZH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1860 FDA 510(k)
Regulation Number
868.1860 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The MSA100BT Peak Flow Meter is a portable spirometry device designed to measure peak expiratory flow (PEF) in patients. It provides a quantitative assessment of airway function by recording the maximum flow achieved during a forced exhalation.

The meter is supplied by Beijing M&B Electronic Instruments Co., Ltd. and is classified as a Class II medical device. It received FDA 510(k) clearance (Traditional, Substantially Equivalent) on 2017‑10‑06, indicating compliance with applicable regulatory requirements.

Frequently asked questions

What is the primary clinical use of the MSA100BT Peak Flow Meter, and how does it help in patient assessment?

The MSA100BT Peak Flow Meter is designed to measure peak expiratory flow (PEF), which quantifies the maximum airflow a patient can exhale forcefully after a deep breath. This helps clinicians assess airway function, particularly in monitoring conditions like asthma or chronic obstructive pulmonary disease (COPD). By providing a numerical reading, it enables patients and providers to track lung function trends over time, aiding in treatment adjustments and early detection of exacerbations.

Is the MSA100BT Peak Flow Meter intended for single-use or repeated use, and how should it be maintained?

The device specifications do not explicitly state reuse restrictions, but the portable, handheld design and lack of mention of sterilization protocols in the provided data suggest it is intended for single-use per patient or multi-use with proper cleaning between patients. Since no cleaning instructions or sterilization claims are listed, users should follow manufacturer guidelines (available from Beijing M&B Electronic Instruments Co., Ltd.) to ensure hygiene and accuracy. Always check the device’s accompanying documentation for specific care recommendations.

What regulatory pathway did the MSA100BT Peak Flow Meter follow to gain market authorization, and what does that mean for compliance?

The MSA100BT Peak Flow Meter received FDA 510(k) clearance under a Traditional submission, classified as Substantially Equivalent (SESE) to a predicate device. This means the manufacturer demonstrated that the device is as safe and effective as a legally marketed comparator, meeting FDA’s regulatory requirements for Class II medical devices. Clinicians and buyers can rely on this clearance as evidence of compliance with U.S. regulatory standards for peak flow meters.

How is the MSA100BT Peak Flow Meter supplied, and are there multiple models or sizes available?

The data does not specify exact packaging details (e.g., box contents or accessories), but the product code (BZH) and registration numbers indicate multiple FEI (Facility Establishment Identifier) codes, which may correspond to different lot numbers or distribution channels rather than distinct physical models. The device itself is described as a single-unit, portable meter, implying a uniform design. For precise sizing or model variations, refer to the manufacturer’s catalog or technical specifications provided by Beijing M&B Electronic Instruments Co., Ltd.

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: Beijing M&B Electronic Instruments Co., Ltd. MSA100BT ... - ManualsLib, Beijing M&B Electronic Instruments Co., Ltd. MSA100BT Manuals, Beijing M&B Electronic Instruments Co., Ltd. MSA100BT ... - manualzz

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Beijing M&B Electronic Instruments Co., Ltd.

Sources (1)

  • FDA 510(k) K170281 24 fields · synced Sep 19, 2026