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B-1000 Spirometer

by Biotrine Corp.

510(k) K844226

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 NumberK844226 Date20 Nov 1984ClearedStatusActive

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  • Withdrawn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)

Full name
B-1000
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, 19 Sep 2026

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

The B-1000 Spirometer is a diagnostic device classified as a spirometer, designed to measure lung function by assessing the volume and flow of air inhaled and exhaled. It provides quantitative data on parameters such as forced vital capacity (FVC) and forced expiratory volume in one second (FEV1), aiding in the evaluation of respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), and other pulmonary disorders.

This device is intended for use in clinical settings, including hospitals, physician offices, and pulmonary function laboratories. Supplied as a reusable medical instrument, the B-1000 Spirometer adheres to FDA regulatory standards, having received a 510(k) clearance under the Traditional pathway in 1984. It is categorized under device class II and regulated under the Federal Food, Drug, and Cosmetic Act (21 CFR 868.1840). No specific sterility or MRI safety information is provided in the available data.

Other devices from Biotrine Corp.

Questions

AI-generated answers, 19 Sep 2026

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

  • What clinical conditions is the B-1000 Spirometer primarily used to evaluate?

    The B-1000 Spirometer is designed to measure lung function by assessing air volume and flow during inhalation and exhalation. It provides quantitative data on parameters like forced vital capacity (FVC) and forced expiratory volume in one second (FEV1), which are critical for diagnosing and monitoring respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), and other pulmonary disorders.

  • Is the B-1000 Spirometer intended for single-use or reusable applications in clinical settings?

    The B-1000 Spirometer is explicitly supplied as a reusable medical instrument, meaning it is intended for repeated use in clinical environments like hospitals, physician offices, and pulmonary function laboratories. This design allows for consistent performance across multiple patient evaluations.

  • What regulatory pathway was followed for the FDA clearance of the B-1000 Spirometer, and when was it cleared?

    The B-1000 Spirometer received FDA clearance under the Traditional 510(k) pathway in 1984. It was determined to be substantially equivalent to a predicate device, adhering to FDA regulatory standards for diagnostic spirometers under the Federal Food, Drug, and Cosmetic Act (21 CFR 868.1840).

  • Are there any specific storage requirements or considerations mentioned for the B-1000 Spirometer?

    The provided data does not include explicit storage instructions for the B-1000 Spirometer. However, as a reusable medical device, it should be stored in a clean, dry environment to maintain hygiene and functionality. Always follow manufacturer guidelines or facility protocols for proper maintenance and cleaning.