510(k) · Cleared
ClearedCaird Technology Spirometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caird Technology · BZG Spirometer, Diagnostic
Cleared on Dec 1, 1998 after a 600-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 28 later devices descend from it.
- Decided
- Dec 1, 1998
- Review
- 600 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 0
28 later devices descend from it, 5 citing it directly.
- This deviceK971336 Caird Technology SpirometerCaird Technology · 1998
- Descendant · cites it directly · 12 of its ownK050074 12-Lead Resting Electrocardiograph, Models CP100 & CP200Welch Allyn, Inc. · 2005
- Descendant · 2 generations on · 11 of its ownK060167 Atria 3100, Atria 6100Cardiac Science Corporation · 2006
- Descendant · cites it directly · 10 of its ownK052158 Welch Allyn Cardioperfect Workstation Version 1.5.0 SoftwareWelch Allyn, Inc. · 2005
- Descendant · 3 generations on · 8 of its ownK160876 PC ECGEdan Instruments, Inc. · 2017
- Descendant · 2 generations on · 4 of its ownK082478 Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62Welch Allyn, Inc. · 2009
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K05007412-Lead Resting Electrocardiograph, Models CP100 & CP200Welch Allyn, Inc. · 2005 · cites it directly12descendants
- K060167Atria 3100, Atria 6100Cardiac Science Corporation · 2006 · 2 generations on11descendants
- K052158Welch Allyn Cardioperfect Workstation Version 1.5.0 SoftwareWelch Allyn, Inc. · 2005 · cites it directly10descendants
- K160876PC ECGEdan Instruments, Inc. · 2017 · 3 generations on8descendants
- K082478Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62Welch Allyn, Inc. · 2009 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971336 | Caird Technology Spirometer | Caird Technology | 1998 | — |
| +1 | K050074 | 12-Lead Resting Electrocardiograph, Models CP100 & CP200 | Welch Allyn, Inc. | 2005 | — |
| +2 | K060167 | Atria 3100, Atria 6100 | Cardiac Science Corporation | 2006 | — |
| +1 | K052158 | Welch Allyn Cardioperfect Workstation Version 1.5.0 Software | Welch Allyn, Inc. | 2005 | — |
| +3 | K160876 | PC ECG | Edan Instruments, Inc. | 2017 | — |
| +2 | K082478 | Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62 | Welch Allyn, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (28)
See all 285 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050074 | 12-Lead Resting Electrocardiograph, Models CP100 & CP200 | 2005 | 12 |
| K052158 | Welch Allyn Cardioperfect Workstation Version 1.5.0 Software | 2005 | 10 |
| K130322 | SPM-300 | 2013 | 3 |
| 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?
- Of its descendants, K050074 (Welch Allyn, Inc., 2005) has gone furthest, with 12 descendants of its own.
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?
Designed for Adult and Pediatric Patients.
For Hospital and Clinic use only.
For Prescription use only.
Some of the conditions for use are as follows:
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 Bronodialators
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971336 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971336: Caird Technology Spirometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971336
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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