Cleared Traditional

K191013 - Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option

K191013 is an FDA 510(k) clearance for Welch Allyn Diagnostic Cardiology Suite..., manufactured by Welch Allyn, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 146-day FDA review.

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

FDA 510(k) Submission Details - K191013

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 140d · This submission: 146d
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 110
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