510(k) · Cleared
ClearedWelch Allyn Cardioperfect Workstation Software (CPWS) V 1.62
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn, Inc. · BZG Spirometer, Diagnostic
Cleared on Mar 9, 2009 as substantially equivalent to K052158 (Welch Allyn, Inc., 2005) after a 193-day review. Its family tree reaches back 2 generations to 1996. 4 later devices descend from it.
- Decided
- Mar 9, 2009
- Review
- 193 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K935732 (1996). 4 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK935732 Cardio Perfect ST 2001Cardio Control BV · 1996
- 1 generation backK052158 Welch Allyn Cardioperfect Workstation Version 1.5.0 SoftwareWelch Allyn, Inc. · 2005
- This deviceK082478 Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62Welch Allyn, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK141546 Vitalograph Model 7000 SpirotracVitalograph (Ireland), Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK201562 SpirotracVitalograph Ireland, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK191013 Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionWelch Allyn, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK142642 Vitalograph Model 6600 CompactVitalograph (Ireland), Ltd. · 2015
Most influential descendants
Showing 4 of 4 · See all- K141546Vitalograph Model 7000 SpirotracVitalograph (Ireland), Ltd. · 2014 · cites it directly2descendants
- K201562SpirotracVitalograph Ireland, Ltd. · 2020 · 2 generations on0descendants
- K191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionWelch Allyn, Inc. · 2019 · cites it directly0descendants
- K142642Vitalograph Model 6600 CompactVitalograph (Ireland), Ltd. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935732 | Cardio Perfect ST 2001 | Cardio Control BV | 1996 | — |
| −1 | K052158 | Welch Allyn Cardioperfect Workstation Version 1.5.0 Software | Welch Allyn, Inc. | 2005 | — |
| 0 (this device) | K082478 | Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62 | Welch Allyn, Inc. | 2009 | — |
| +1 | K141546 | Vitalograph Model 7000 Spirotrac | Vitalograph (Ireland), Ltd. | 2014 | — |
| +2 | K201562 | Spirotrac | Vitalograph Ireland, Ltd. | 2020 | — |
| +1 | K191013 | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option | Welch Allyn, Inc. | 2019 | 1 |
| +2 | K142642 | Vitalograph Model 6600 Compact | Vitalograph (Ireland), Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZG device
- #1 K251777 MESI mTABLET SPIROscore 13.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052158 | Welch Allyn Cardioperfect Workstation Version 1.5.0 SoftwareSummary page 1…Code BZG) and Cardiovascular (Product Code LOS). Predicate Device: CardioPerfect Workstation Software Version 1.5.0 (K052 158) Welch Allyn CPWS V 1.6.2 Page 1 of 4 Abbreviated 510(k… | 2005 |
| † | K072449 | CP100 & 200 12-Lead Resting Electrocardiographs | 2007 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 9.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K141546 (Vitalograph (Ireland), Ltd., 2014) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K052158.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · BZG
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZG
362in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZG
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZG
1in 2025
MAUDE reports naming product code BZG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 121 | 0 | 1 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 8 | 141 | 0 | 0 |
| 2010 | 4 | 181 | 0 | 0 |
| 2011 | 6 | 278 | 0 | 1 |
| 2012 | 3 | 59 | 0 | 2 |
| 2013 | 3 | 266 | 0 | 1 |
| 2014 | 5 | 154 | 0 | 1 |
| 2015 | 5 | 273 | 0 | 1 |
| 2016 | 4 | 235 | 0 | 1 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 3 | 146 | 0 | 1 |
| 2020 | 5 | 126 | 0 | 2 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 3 |
| 2023 | 5 | 362 | 0 | 2 |
| 2024 | 2 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (394 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082478 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082478: Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082478
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026