510(k) · Cleared
Recalled · Class II · 2024Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
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 10, 2019 as substantially equivalent to K082478 (Welch Allyn, Inc., 2009) after a 146-day review. Its family tree reaches back 3 generations to 1996. It has been recalled once.
- Decided
- Sep 10, 2019
- Review
- 146 days
- Class
- Class II
- Product code
- BZG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K935732 (1996). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK935732 Cardio Perfect ST 2001Cardio Control BV · 1996
- 2 generations backK052158 Welch Allyn Cardioperfect Workstation Version 1.5.0 SoftwareWelch Allyn, Inc. · 2005
- 1 generation backK082478 Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62Welch Allyn, Inc. · 2009
- This deviceK191013 Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionWelch Allyn, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935732 | Cardio Perfect ST 2001 | Cardio Control BV | 1996 | — |
| −2 | 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 | — |
| 0 (this device) | K191013 | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option | Welch Allyn, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 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 |
|---|---|---|---|
| * | K082478 | Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62Summary page 4…ulation: DPS, 870.2340 Predicate Device: Welch Allyn CardioPerfect® Workstation Software™ (CPWS) 901047 CARDIOPULMONAY ECG SYSTEM (K082478) Reference Device: Welch Allyn® RScribe™ (K120865) 901127 ELECTROCARDIOGRAPH Backgro… | 2009 |
| † | K120865 | Rscribe Electrocardiograph | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 11, 2024 | Class II | Z-0324-2025 | Software design | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 9.4 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K082478.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Welch Allyn® Diagnostic Cardiology Suite™ is a prescription device intended for use by physicians, other licensed health care practitioners, and trained personnel who are acting on the orders of a physician. Welch Allyn Diagnostic Cardiology Suite is intended for use in medical clinics, physician offices and hospital settings to acquire, analyze, display, transmit and print certain physiological signals identified below and provide the data for…
Read the full statement (375 words)
The Welch Allyn® Diagnostic Cardiology Suite™ is a prescription device intended for use by physicians, other licensed health care practitioners, and trained personnel who are acting on the orders of a physician. Welch Allyn Diagnostic Cardiology Suite is intended for use in medical clinics, physician offices and hospital settings to acquire, analyze, display, transmit and print certain physiological signals identified below and provide the data for consideration by a physician.
Welch Allyn Diagnostic Cardiology Suite utilizes a software platform to support 12-lead diagnostic resting ECG and diagnostic Spirometry applications and is designed to operate within the inherent capabilities of an off-the-shelf laptop or PC Windows operating system. Welch Allyn Diagnostic Cardiology Suite also provides functions related to patient data management including communication with electronic medical records systems. Welch Allyn Diagnostic Cardiology Suite Resting ECG’s are intended to be taken with the patient in the supine position and offer VERITAS™ resting ECG algorithm to generate measurements and advisory statements for review and interpretation by the physician.
Welch Allyn Diagnostic Cardiology Suite is not intended to be used as a physiological vital signs monitor, not intended to be used in a mobile medical environment (e.g. ambulance, helicopter), in magnetic resonance (MR) environments, in operating theaters, nor in conjunction with high frequency surgical equipment.
Indications for Welch Allyn Diagnostic Cardiology Suite ECG range from routine screening of cardiac health in the physician office environment to directed diagnostic differentiation in a hospital cardiology department. Welch Allyn Diagnostic Cardiology Suite ECG is indicated for patients of all ages.
Welch Allyn Diagnostic Cardiology Suite Spirometry is indicated for pulmonary function testing, providing forced expiratory flow-volume and time measurements. The device is intended to be a general assessment tool assisting the clinician in the diagnosis of pulmonary function. These devices are commonly used on patients with occupational exposure to dust or chemicals; presenting with symptoms such as chronic cough, shortness of breath and wheezing; disorders such as interstitial lung disease, bronchitis, asthma, and COPD; or other patients where the clinician determines these pulmonary function measurements are needed. Welch Allyn Diagnostic Cardiology Suite with Spirometry is indicated for adult and pediatric patients age 6 years and older and should only be used with patients able to understand the instructions for performing the test.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191013 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191013: Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191013
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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