# K141582: CP150 Electrocardiograph with Spirometry Option

- Pathway: 510(k) (Special)
- Applicant: Welch Allyn
- Decided: Jul 11, 2014 after 28 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K895520 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131573: CP150 Electrocardiograph, Welch Allyn, Inc. (2013) Summary page 2.

## Recalls of this device
- Mar 24, 2025 · Class II · Z-1560-2025: There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not app
- Jun 3, 2024 · Class II · Z-2323-2024: During manufacturing, the step to install an Electromagnetic Interference (EMI) Absorber was omitted. The purpose of the EMI absorber is to prevent EMI leakage that might potentially affect other devi

## Indications for use
The electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function. The 12-lead optional interpretation algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information. The Spirometer is a device that measures lung air volume and airflow rate for pulmonary disease diagnosis and screening. These measurements provide information about a patient's pulmonary function which may be compared with normal values or the patient's previous values. The device is designed to test pulmonary function and obtain spirometric indices for: * adult and pediatric patients 12 years and older, * hospital and clinic use only.

Source page: https://510kreport.com/device/K141582
Methodology: https://510kreport.com/methodology