Cleared Abbreviated

K093907 - WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE

K093907 is an FDA 510(k) clearance for WELCH ALLYN NON INVASIVE BLOOD PRESSURE..., manufactured by Welch Allyn, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Abbreviated 510(k) pathway after a 113-day FDA review.

K093907 · Welch Allyn, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
113d
Days
Class 2
Risk

K093907 is an FDA 510(k) clearance for the WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE. 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 April 14, 2010 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K093907

510(k) Number K093907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2009
Decision Date April 14, 2010
Days to Decision 113 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 125d · This submission: 113d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 Consultant

Intertek Testing Services
JAY KOGOMA

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 1149
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K093907.
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K093907 · WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE
Download PDF FDA Summary Welch Allyn, Inc.