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12-LEAD Resting Electrocardiograph, Models CP100 & CP200

by Welch Allyn, Inc.

510(k) K050074

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK050074 Date22 Mar 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DPS
Device Class
Class II
Regulation
21 CFR Part 870.2340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A 12-lead resting electrocardiograph is a medical device used to record the electrical activity of the heart. The Welch Allyn CP100 and CP200 models are specific versions of this device type, designed for acquiring and displaying electrocardiogram (ECG) tracings in a clinical setting.

These devices are supplied as reusable equipment and operate on either battery or AC power. They include features such as a full alphanumeric keyboard, LCD display, and user-programmable reports. The device received FDA 510(k) clearance (K050074) and is classified under product code DPS with cardiovascular advisory committee review.

Other devices from Welch Allyn, Inc.

See all devices from Welch Allyn, Inc. →

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Welch Allyn CP100 and CP200 used for?

    The Welch Allyn CP100 and CP200 are 12-lead resting electrocardiographs designed to acquire and display electrocardiogram (ECG) tracings in a clinical setting by recording the heart's electrical activity.

  • Are the Welch Allyn CP100 and CP200 reusable or single-use devices?

    The Welch Allyn CP100 and CP200 are supplied as reusable equipment, meaning they are intended for multiple uses after appropriate cleaning and maintenance between patients.

  • What power options do the Welch Allyn CP100 and CP200 support?

    The Welch Allyn CP100 and CP200 operate on either battery or AC power, providing flexibility for use in various clinical environments where power sources may vary.

  • What features are included on the Welch Allyn CP100 and CP200 electrocardiographs?

    These devices include a full alphanumeric keyboard, LCD display, and user-programmable reports to support efficient ECG acquisition, viewing, and customization in clinical workflows.

  • What regulatory pathway was used for the Welch Allyn CP100 and CP200?

    The Welch Allyn CP100 and CP200 received FDA 510(k) clearance under submission number K050074, demonstrating substantial equivalence to a legally marketed predicate device.