# K072449: CP100 & 200 12-Lead Resting Electrocardiographs

- Pathway: 510(k) (Abbreviated)
- Applicant: Welch Allyn, Inc.
- Decided: Nov 29, 2007 after 90 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.
7 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001265: Welch Allyn Instrument Interface Module, Welch Allyn, Inc. (2000) Summary page 1.
- 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.

## Most influential descendants
- K102767: Cardio XP (2011), 4 descendants of its own
- K113306: Cardio 7 (2012), 3 descendants of its own
- K220535: Cardio10 (2022), 2 descendants of its own
- K131573: CP150 Electrocardiograph (2013), 1 descendant of its own
- K231160: Cardio Q50, Cardio Q70 (2023), 0 descendants of its own

## Indications for use
The electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function. The 12-lead ECG interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information. The optional Spirometry module is indicated for use in clinical situations to assess a patient's pulmonary health status and evaluate symptoms, signs, or abnormal laboratory test results.

Source page: https://510kreport.com/device/K072449
Methodology: https://510kreport.com/methodology