510(k) Report

510(k) · Cleared

Cleared

Welch Allyn Cardioperfect Workstation Version 1.5.0 Software

K052158510(k) SpecialCleared Sep 8, 200530-day reviewClass II21 CFR 868.1840

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1997: 1 other ancestor2015: 2 descendants cleared2009: 2 descendants cleared2014: 2 descendants cleared2017: 1 descendant cleared2019: 1 descendant cleared2011: 1 descendant cleared2020: 1 descendant clearedK935732 · Cardio Perfect ST 2001 · Cardio Control BV · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants K935732 · Cardio Perfect ST 2001 · Cardio Control BV · 19960
  1. Root · 1 generation backK935732 Cardio Perfect ST 2001Cardio Control BV · 1996
  2. This deviceK052158 Welch Allyn Cardioperfect Workstation Version 1.5.0 SoftwareWelch Allyn, Inc. · 2005
  3. Descendant · cites it directly · 4 of its ownK082478 Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62Welch Allyn, Inc. · 2009
  4. Descendant · 2 generations on · 2 of its ownK141546 Vitalograph Model 7000 SpirotracVitalograph (Ireland), Ltd. · 2014
  5. Descendant · cites it directly · 1 of its ownK090602 Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp. · 2009
  6. Descendant · 3 generations on · 0 of its ownK201562 SpirotracVitalograph Ireland, Ltd. · 2020
  7. 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

2009: 22011: 12014: 22015: 22017: 12019: 12020: 1
2009high 2 (2009) · low 0 (2010)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
−1K935732Cardio Perfect ST 2001Cardio Control BV1996—
0 (this device)K052158Welch Allyn Cardioperfect Workstation Version 1.5.0 SoftwareWelch Allyn, Inc.2005—
+1K082478Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62Welch Allyn, Inc.2009—
+2K141546Vitalograph Model 7000 SpirotracVitalograph (Ireland), Ltd.2014—
+1K090602Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp.2009—
+3K201562SpirotracVitalograph Ireland, Ltd.2020—
+2K191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionWelch Allyn, Inc.20191

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201110
201420
201520
201710
201910
202010
FIG. 1 — Lineage of K052158, 1996–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251777 MESI mTABLET SPIROscore 13.0 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K962854Hardware: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…
Cardio Control BV1997—
*K935732Cardio Perfect ST 2001
Summary 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…
Cardio Control BV1996—
*K971336Caird Technology Spirometer
Summary 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…
Caird Technology1998—

Also cleared against K962854: 1 other device →

What descends from it? (10)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K082478Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62Welch Allyn, Inc.20094
K090602Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp.20091
K162463Matrix Data Management SystemGlobal Instrumentation, LLC20170
K120577MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DXMedikro OY20150
K133428Medikro Nano, Medikro Primo and Medikro ProMedikro OY20140

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K082478 (Welch Allyn, Inc., 2009) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K962854.

How does its category compare?

All BZG devices

BZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BZG

2in 2024

2007: 32008: 32009: 82010: 42011: 62012: 32013: 32014: 52015: 52016: 42017: 22018: 12019: 32020: 52021: 12022: 22023: 52024: 22026 (partial year): 1
2007high 8 (2009) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZG

362in 2023

2007: 121 days median2008: 209 days median2009: 141 days median2010: 181 days median2011: 278 days median2012: 59 days median2013: 266 days median2014: 154 days median2015: 273 days median2016: 235 days median2019: 146 days median2020: 126 days median2023: 362 days median
2007high 362 (2023) · low 59 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BZG

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · BZG

1in 2025

2007: 12011: 12012: 22013: 12014: 12015: 12016: 12017: 12018: 12019: 12020: 22021: 12022: 32023: 22024: 32025: 1
2007high 3 (2022) · low 0 (2008)2025

MAUDE reports naming product code BZG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007312101
2008320900
2009814100
2010418100
2011627801
201235902
2013326601
2014515401
2015527301
2016423501
20172—01
20181—01
2019314601
2020512602
20211—01
20222—03
2023536202
20242—13
20250—01
20261—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.

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