510(k) · Cleared
ClearedWelch Allyn Cardioperfect Workstation Version 1.5.0 Software
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 Sep 8, 2005 as substantially equivalent to K962854 (Cardio Control BV, 1997) and 2 other predicates after a 30-day review. Its family tree reaches back 1 generation to 1996. 10 later devices descend from it.
- Decided
- Sep 8, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K935732 (1996). 3 ancestors in all. 10 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK935732 Cardio Perfect ST 2001Cardio Control BV · 1996
- This deviceK052158 Welch Allyn Cardioperfect Workstation Version 1.5.0 SoftwareWelch Allyn, Inc. · 2005
- Descendant · cites it directly · 4 of its ownK082478 Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62Welch Allyn, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK141546 Vitalograph Model 7000 SpirotracVitalograph (Ireland), Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK090602 Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp. · 2009
- Descendant · 3 generations on · 0 of its ownK201562 SpirotracVitalograph Ireland, Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK191013 Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionWelch Allyn, Inc. · 2019 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K082478Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62Welch Allyn, Inc. · 2009 · cites it directly4descendants
- K141546Vitalograph Model 7000 SpirotracVitalograph (Ireland), Ltd. · 2014 · 2 generations on2descendants
- K090602Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp. · 2009 · cites it directly1descendant
- K201562SpirotracVitalograph Ireland, Ltd. · 2020 · 3 generations on0descendants
- K191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionWelch Allyn, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935732 | Cardio Perfect ST 2001 | Cardio Control BV | 1996 | — |
| 0 (this device) | K052158 | Welch Allyn Cardioperfect Workstation Version 1.5.0 Software | Welch Allyn, Inc. | 2005 | — |
| +1 | K082478 | Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62 | Welch Allyn, Inc. | 2009 | — |
| +2 | K141546 | Vitalograph Model 7000 Spirotrac | Vitalograph (Ireland), Ltd. | 2014 | — |
| +1 | K090602 | Cardiodynamics Bioz RX, Model 7101-Sys | Cardiodynamics International Corp. | 2009 | — |
| +3 | K201562 | Spirotrac | Vitalograph Ireland, Ltd. | 2020 | — |
| +2 | K191013 | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option | Welch Allyn, Inc. | 2019 | 1 |
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 |
|---|---|---|
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 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? (3)
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 |
|---|---|---|---|
| * | K962854 | Hardware:Cardio Perfect Portable, Cardio Perfect MD and Software:Cardio Perfect (V. 4.0…Summary page 1….1025 DXN: 21 CFR 870.1130 BZG: 21 CFR 868.1840 Predicate Device: ECG-resting, CardioPerfect with Means, K962854 ECG-stress, CardioPerfect ST, K935732 Caird Technology Spirometer, K971336 Descrip… | 1997 |
| * | K935732 | Cardio Perfect ST 2001Summary page 1…BZG: 21 CFR 868.1840 Predicate Device: ECG-resting, CardioPerfect with Means, K962854 ECG-stress, CardioPerfect ST, K935732 Caird Technology Spirometer, K971336 Description: CardioPerfect Workstation software is used t… | 1996 |
| * | K971336 | Caird Technology SpirometerSummary page 1…ice: ECG-resting, CardioPerfect with Means, K962854 ECG-stress, CardioPerfect ST, K935732 Caird Technology Spirometer, K971336 Description: CardioPerfect Workstation software is used to create a computer platform on whic… | 1998 |
What descends from it? (10)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082478 | Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62 | 2009 | 4 |
| K090602 | Cardiodynamics Bioz RX, Model 7101-Sys | 2009 | 1 |
| K162463 | Matrix Data Management System | 2017 | 0 |
| K120577 | MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX | 2015 | 0 |
| K133428 | Medikro Nano, Medikro Primo and Medikro Pro | 2014 | 0 |
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?
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 (392 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.
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052158: Welch Allyn Cardioperfect Workstation Version 1.5.0 Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052158
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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