Cleared Special

K023495 - WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK)

K023495 is an FDA 510(k) clearance for WELCH ALLYN VITALS SOFTWARE DEVELOPERS ..., manufactured by Welch Allyn, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Special 510(k) pathway after a 13-day FDA review.

K023495 · Welch Allyn, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
13d
Days
Class 2
Risk

K023495 is an FDA 510(k) clearance for the WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK). Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on October 31, 2002 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight 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 - K023495

510(k) Number K023495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2002
Decision Date October 31, 2002
Days to Decision 13 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 125d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 1225
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K023495 · WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK)
Download PDF FDA Summary Welch Allyn, Inc.