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Fukuda Sangyo Model SpiroAnalyzer ST-180

by Spirosoft Northamerica, Inc.

510(k) K943546

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK943546 Date23 Feb 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BZG
Device Class
Class II
Regulation
21 CFR Part 868.1840
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Fukuda Sangyo Model SpiroAnalyzer ST-180 is a diagnostic spirometer, a device used to measure lung function by assessing airflow and lung volumes. It evaluates respiratory health by generating spirometry readings, including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and peak expiratory flow (PEF), aiding in the diagnosis and monitoring of pulmonary conditions such as asthma, chronic obstructive pulmonary disease (COPD), and other respiratory disorders.

This device is intended for use in clinical settings, including anesthesia and respiratory care environments, where precise lung function assessment is required. Supplied as a reusable medical instrument, it adheres to regulatory standards under FDA classification II (BZG) and is authorized under the 510(k) clearance process (K943546). The SpiroAnalyzer ST-180 operates under the regulatory framework of 21 CFR 868.1840, ensuring compliance with diagnostic medical device requirements. No specific sterility or MRI safety information is provided in the available data.