Cleared Traditional

K191013 - Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option (FDA 510(k) Clearance)

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

K191013 · Welch Allyn, Inc. · Anesthesiology device
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Sep 2019
Decision
146d
Days
Class 2
Risk

K191013 is an FDA 510(k) clearance for the Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Milwaukee, US). The FDA issued a Cleared decision on September 10, 2019 after a review of 146 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.

View all Welch Allyn, Inc. devices

Submission Details

510(k) Number K191013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2019
Decision Date September 10, 2019
Days to Decision 146 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
7d slower than avg
Panel avg: 139d · This submission: 146d
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.