Cleared Special

K052158 - WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE

K052158 is an FDA 510(k) clearance for WELCH ALLYN CARDIOPERFECT WORKSTATION V..., manufactured by Welch Allyn, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Special 510(k) pathway after a 30-day FDA review.

K052158 · Welch Allyn, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
30d
Days
Class 2
Risk

K052158 is an FDA 510(k) clearance for the WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on September 8, 2005 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K052158

510(k) Number K052158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2005
Decision Date September 08, 2005
Days to Decision 30 days
Submission Type Special
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
110d faster than avg
Panel avg: 140d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 158
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