Cleared Traditional

K000599 - VITALOGRAPH BASE STATION

K000599 is an FDA 510(k) clearance for VITALOGRAPH BASE STATION, manufactured by Vitalograph, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K000599 · Vitalograph, Inc. · Anesthesiology device
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Sep 2000
Decision
199d
Days
Class 2
Risk

K000599 is an FDA 510(k) clearance for the VITALOGRAPH BASE STATION. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Vitalograph, Inc. (Lenexa, US). The FDA issued a Cleared decision on September 8, 2000 after a review of 199 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vitalograph, Inc. devices

FDA 510(k) Submission Details - K000599

510(k) Number K000599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2000
Decision Date September 08, 2000
Days to Decision 199 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 140d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZG Device Classification - Class 2, Special Controls

Product Code BZG Spirometer, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BZG Spirometer, Diagnostic

All 110
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K000599.
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K993921 · Ndd Medical Technologies · May 2000
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K992823 · Schiller AG · May 2000
COLLINS CPL
K992743 · Collins Medical, Inc. · Sep 1999