# K082478: Welch Allyn Cardioperfect Workstation Software (CPWS)  V 1.62

- Pathway: 510(k) (Abbreviated)
- Applicant: Welch Allyn, Inc.
- Decided: Mar 9, 2009 after 193 days
- Product code: BZG (Spirometer, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 868.1840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K935732 (1996). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052158: Welch Allyn Cardioperfect Workstation Version 1.5.0 Software, Welch Allyn, Inc. (2005) Summary page 1.

## Most influential descendants
- K141546: Vitalograph Model 7000 Spirotrac (2014), 2 descendants of its own
- K201562: Spirotrac (2020), 0 descendants of its own
- K191013: Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option (2019), 0 descendants of its own
- K142642: Vitalograph Model 6600 Compact (2015), 0 descendants of its own

## Indications for use
The CardioPerfect Workstation software and associated accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals, as identified below, for the purpose of assisting the clinician in the diagnosis and monitoring of various diseases and/or treatment regimens. The CardioPerfect Workstation software also provides non-diagnostic functions such as patient management, data security, search tools for patient and/or test records and support for exporting data to Electronic Medical Record systems. The CardioPerfect Workstation and associated accessories are intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on both adult and pediatric patients, subject to any specific contraindications identified below. Stress Electrocardiograph - Intended Use Using the optional ECG module and associated accessories the user can acquire, view, store and print ECG waveforms. Resting Electrocardiograph - Intended Use The same as defined for stress ECG plus the ability to use optional algorithms (MEANS) to generate measurements, data presentations, graphical presentations and interpretive statements on an advisory basis. These are presented for review and interpretation by the clinician. Spirometry - Intended Use Using the optional spirometry module and associated accessories to acquire, view, store and print measures and waveforms of pulmonary function. The spirometer should only be used with patients able to understand the instructions for performing the test. Ambulatory Blood Pressure - Intended Use Using the optional ABP module and associated accessories the user can acquire, retrieve, view, store and print patient ambulatory blood pressure history. Electrocardiograph - Indications for Use Indications for electrocardiography range from routine screening of cardiac health in the physician office environment to directed diagnostic differentiation in a hospital cardiology department. Spirometry - Indications for Use Indications for spirometry include, but are not limited to, the following: Shortness of breath Chronic cough Occupational exposure to dust or chemicals Assist in the diagnosis of Bronchitis Assist in the diagnosis of Asthma Wheezing Assist in the monitoring of bronchodilator Ambulatory Blood Pressure - Indications for Use Indications for ambulatory blood pressure measurement (as listed in Journal of Hypertension 2003, 21:821-848, E. O'Brien et. al.) include, but are not limited to, the following: suspected "white coat" hypertension Suspected nocturnal hypertension To establish dipper status Resistant hypertension Elderly patient To monitor antihypertensive drug treatment Type I diabetes Hypertension of pregnancy Evaluations of hypotension Autonomic failure Masked hypertension

Source page: https://510kreport.com/device/K082478
Methodology: https://510kreport.com/methodology