Cleared Traditional

K073155 - VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)

K073155 is an FDA 510(k) clearance for VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6), manufactured by Vitalograph (Ireland) , Ltd.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K073155 · Vitalograph (Ireland) , Ltd. · Anesthesiology device
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Jun 2008
Decision
209d
Days
Class 2
Risk

K073155 is an FDA 510(k) clearance for the VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6). Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Vitalograph (Ireland) , Ltd. (Ennis, Co. Clare, IE). The FDA issued a Cleared decision on June 4, 2008 after a review of 209 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 (Ireland) , Ltd. devices

FDA 510(k) Submission Details - K073155

510(k) Number K073155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2007
Decision Date June 04, 2008
Days to Decision 209 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 140d · This submission: 209d
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 147
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K073155.
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