Cleared Special

K141582 - CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION

K141582 is an FDA 510(k) clearance for CP150 ELECTROCARDIOGRAPH WITH SPIROMETR..., manufactured by Welch Allyn. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Special 510(k) pathway after a 28-day FDA review.

K141582 · Welch Allyn · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
28d
Days
Class 2
Risk

K141582 is an FDA 510(k) clearance for the CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Welch Allyn (Skaneateles Falls, US). The FDA issued a Cleared decision on July 11, 2014 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 - K141582

510(k) Number K141582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2014
Decision Date July 11, 2014
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 494
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K141582.
MAC 800 Resting ECG Analysis System
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K142105 · Mortara Instrument, Inc. · Sep 2014
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K131858 · Guangdong Biolight Meditech Co., Ltd. · Jun 2014
CONTEC ELECTROCARDIOGRAPH
K131900 · Contec Medical System Co., Ltd. · Mar 2014
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K131503 · Edan Instruments, Inc. · Feb 2014
K141582 · CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION
Download PDF FDA Summary Welch Allyn