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Vitalograph Base Station

by Vitalograph, Inc. 510(k)

Active United States

510(k) K000599

Overview

The Vitalograph Base Station is a diagnostic spirometer device classified under FDA class 2 with product code BZG. It received FDA 510(k) clearance K000599 on September 8, 2000, and is substantially equivalent to a predicate device. The device is associated with the medical specialty of anesthesiology and regulation number 868.1840.

It is manufactured by Vitalograph, Inc. and was submitted for clearance on February 22, 2000. The device is intended for use in clinical settings and is supplied as a non-sterile, reusable system. No information regarding MRI safety, specific sizes, storage conditions, or single-use designation is provided in the data.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK000599 Date8 Sep 2000ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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Questions

  • What is the Vitalograph Base Station used for?

    The Vitalograph Base Station is a diagnostic spirometer intended for use in clinical settings, specifically within the medical specialty of anesthesiology, to measure lung function as part of respiratory assessment.

  • Is the Vitalograph Base Station sterile or single-use?

    The device is supplied as a non-sterile, reusable system, meaning it is not provided in a sterile condition and is designed for multiple uses after appropriate cleaning and disinfection between patients.

  • What regulatory pathway was used for the Vitalograph Base Station?

    The Vitalograph Base Station received FDA 510(k) clearance under submission number K000599 on September 8, 2000, demonstrating substantial equivalence to a legally marketed predicate device under the traditional review process.