Cleared Traditional

K052176 - FLOWHANDY ZAN100 USB (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K052176 · Zan Messgerate GmbH · Anesthesiology device
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Jan 2006
Decision
155d
Days
Class 2
Risk

K052176 is an FDA 510(k) clearance for the FLOWHANDY ZAN100 USB. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Zan Messgerate GmbH (Louisville, US). The FDA issued a Cleared decision on January 12, 2006 after a review of 155 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 Zan Messgerate GmbH devices

Submission Details

510(k) Number K052176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2005
Decision Date January 12, 2006
Days to Decision 155 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 139d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

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