Cleared Special

K013478 - DYNAPULSE 5200A PATHWAY BLOOD PRESSURE ...

K013478 is the FDA 510(k) clearance for DYNAPULSE 5200A PATHWAY BLOOD PRESSURE ... by Pulse Metric, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Special 510(k) pathway after a 83-day FDA review.

K013478 · Pulse Metric, Inc. · Cardiovascular device
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Jan 2002
Decision
83d
Days
Class 2
Risk

K013478 is an FDA 510(k) clearance for the DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Pulse Metric, Inc. (San Diego, US). The FDA issued a Cleared decision on January 10, 2002 after a review of 83 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 Pulse Metric, Inc. devices

Submission Details

510(k) Number K013478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2001
Decision Date January 10, 2002
Days to Decision 83 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 517
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K013478.
HL168F
K020766 · Health & Life Co., Ltd. · Apr 2002
A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS
K012472 · A&D Engineering, Inc. · Feb 2002
HL168E
K014122 · Health & Life Co., Ltd. · Jan 2002
MODIFICATION TO: HL168W TOUCH SCREEN
K013033 · Health & Life Co., Ltd. · Oct 2001
MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR
K012310 · Health & Life Co., Ltd. · Aug 2001
LIFESOURCE MODELS UA-787, UA 787PC, UA-787T
K012013 · A&D Engineering, Inc. · Jul 2001