Cleared Traditional

K160116 - SpiroScout

K160116 is an FDA 510(k) clearance for SpiroScout, manufactured by Ganshorn Medizin Electronic GmbH. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K160116 · Ganshorn Medizin Electronic GmbH · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
262d
Days
Class 2
Risk

K160116 is an FDA 510(k) clearance for the SpiroScout. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Ganshorn Medizin Electronic GmbH (Niederlauer, DE). The FDA issued a Cleared decision on October 7, 2016 after a review of 262 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 Ganshorn Medizin Electronic GmbH devices

FDA 510(k) Submission Details - K160116

510(k) Number K160116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2016
Decision Date October 07, 2016
Days to Decision 262 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
122d slower than avg
Panel avg: 140d · This submission: 262d
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.

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All 50
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