Cleared Traditional

K161676 - Q13 SPIROLYSER®

K161676 is an FDA 510(k) clearance for Q13 SPIROLYSER, manufactured by Fim Medical. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K161676 · Fim Medical · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
125d
Days
Class 2
Risk

K161676 is an FDA 510(k) clearance for the Q13 SPIROLYSER®. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Fim Medical (Villeurbanne Cedex , Rhone, FR). The FDA issued a Cleared decision on October 20, 2016 after a review of 125 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K161676

510(k) Number K161676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2016
Decision Date October 20, 2016
Days to Decision 125 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
15d faster than avg
Panel avg: 140d · This submission: 125d
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 Consultant

Kamm & Associates
DANIEL KAMM

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 158
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