# K050074: 12-Lead Resting Electrocardiograph, Models CP100 & CP200

- Pathway: 510(k) (Abbreviated)
- Applicant: Welch Allyn, Inc.
- Decided: Mar 22, 2005 after 69 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K895520 (1990). 4 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031422: Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models 860286, 860287, 860288, 860289, 860290, 860291, Philips Medical Systems (2003) Summary page 1.
- K971336: Caird Technology Spirometer, Caird Technology (1998) Summary page 1.

## Most influential descendants
- K060167: Atria 3100, Atria 6100 (2006), 11 descendants of its own
- K160876: PC ECG (2017), 8 descendants of its own
- K171942: Electrocardiograph (2018), 3 descendants of its own
- K170995: Electrocardiograph (2017), 3 descendants of its own
- K212278: Electrocardiograph (2022), 2 descendants of its own

## Indications for use
The Welch Allyn Printing Electrocardiography and Spirometry Products (Subject Devices) are intended for use by trained operators in health facilities. The subject Devices will provide the following diagnostic functions: * Acquiring, viewing, storing and printing ECG waveforms patients using ECG Front End modules and associated accessories that provide signal acquisition for up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the body. * Using optional algorithms to generate measurements, data presentations, graphical presentations and interpretive statements on an advisory basis for patients of sixteen (16) years of age and above. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the results of the physical examination, the ECG tracings, and other clinical findings. * Using the optional Spirometry module and associated accessories to acquire, view, store and print measures and waveforms of pulmonary function including, but not limited to, maximal volume and flow of air that can be moved in and out of a patient's lungs. These measures are used in the diagnosis and monitoring of lung diseases and interventions for the treatment of certain lung diseases. The Spirometer may be used with patients that are able to understand the instructions for performing the test, however normal values and interpretive results are not calculated for children under the age of six.

Source page: https://510kreport.com/device/K050074
Methodology: https://510kreport.com/methodology