# K052158: Welch Allyn Cardioperfect Workstation Version 1.5.0 Software

- Pathway: 510(k) (Special)
- Applicant: Welch Allyn, Inc.
- Decided: Sep 8, 2005 after 30 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: 1 generation back to K935732 (1996). 3 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962854: Hardware:Cardio Perfect Portable, Cardio Perfect MD and Software:Cardio Perfect (V. 4.0 and UP for Dos), Cardio Perfect, Cardio Control BV (1997) Summary page 1.
- K935732: Cardio Perfect ST 2001, Cardio Control BV (1996) Summary page 1.
- K971336: Caird Technology Spirometer, Caird Technology (1998) Summary page 1.

## Most influential descendants
- K082478: Welch Allyn Cardioperfect Workstation Software (CPWS)  V 1.62 (2009), 4 descendants of its own
- K141546: Vitalograph Model 7000 Spirotrac (2014), 2 descendants of its own
- K090602: Cardiodynamics Bioz RX, Model 7101-Sys (2009), 1 descendant 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

## 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. Electrocardiograph - Stress Using the optional ECG module and associated accessories the user can acquire, view, store and print ECG waveforms. Indications for electrocardiography range from routine screening of cardiac health in the physician office environment to directed diagnostic differentiation in a hospital cardiology department. Electrocardiograph - Resting 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 for patients sixteen (16) years of age and above. These are presented for review and interpretation by the clinician. Ambulatory Blood Pressure Using the optional ABP module and associated accessories the user can acquire, retrieve, view, store and print patient ambulatory blood pressure history. 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 Spirometry Using the optional spirometry module and associated accessories to acquire, view, store and print measures and waveforms of pulmonary function. Normal values and comparative results are not calculated for children under the age of six. 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

Source page: https://510kreport.com/device/K052158
Methodology: https://510kreport.com/methodology