Cleared Special

K024005 - WELCH ALLYN VITAL SIGN MONITOR WITH MP506

K024005 is an FDA 510(k) clearance for WELCH ALLYN VITAL SIGN MONITOR WITH MP506, 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 70-day FDA review.

K024005 · Welch Allyn, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
70d
Days
Class 2
Risk

K024005 is an FDA 510(k) clearance for the WELCH ALLYN VITAL SIGN MONITOR WITH MP506. 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 February 12, 2003 after a review of 70 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.

View all Welch Allyn, Inc. devices

FDA 510(k) Submission Details - K024005

510(k) Number K024005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2002
Decision Date February 12, 2003
Days to Decision 70 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
55d faster than avg
Panel avg: 125d · This submission: 70d
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

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