510(k) · Cleared
ClearedVitalograph Model 7000 Spirotrac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitalograph (Ireland), Ltd. · BZG Spirometer, Diagnostic
Cleared on Sep 3, 2014 as substantially equivalent to K082478 (Welch Allyn, Inc., 2009) and 1 other predicate after an 85-day review. Its family tree reaches back 5 generations to 1994. 2 later devices descend from it.
- Decided
- Sep 3, 2014
- Review
- 85 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K943404 (1994). 15 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK943404 3301 Pulse OximeterBci Intl., Inc. · 1994
- 4 generations backK013171 3420 Digit Pulse Oximeter, Model 3420Bci, Inc. · 2002
- 3 generations backK043528 SpirotelMir Medical Intl. Research Srl · 2005
- 2 generations backK061712 Spirobank IIMir Medical Intl. Research Srl · 2006
- 1 generation backK103530 SpirodocMedical International Research USA, Inc. · 2011
- This deviceK141546 Vitalograph Model 7000 SpirotracVitalograph (Ireland), Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK201562 SpirotracVitalograph Ireland, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK142642 Vitalograph Model 6600 CompactVitalograph (Ireland), Ltd. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943404 | 3301 Pulse Oximeter | Bci Intl., Inc. | 1994 | — |
| −4 | K013171 | 3420 Digit Pulse Oximeter, Model 3420 | Bci, Inc. | 2002 | — |
| −3 | K043528 | Spirotel | Mir Medical Intl. Research Srl | 2005 | — |
| −2 | K061712 | Spirobank II | Mir Medical Intl. Research Srl | 2006 | — |
| −1 | K103530 | Spirodoc | Medical International Research USA, Inc. | 2011 | — |
| 0 (this device) | K141546 | Vitalograph Model 7000 Spirotrac | Vitalograph (Ireland), Ltd. | 2014 | — |
| +1 | K201562 | Spirotrac | Vitalograph Ireland, Ltd. | 2020 | — |
| +1 | K142642 | Vitalograph Model 6600 Compact | Vitalograph (Ireland), Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (2)
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 5…868.1840. Product Code BZG. 7. Predicate Device: Manufacturer : Welch Allyn Device Name : CardioPerfect Workstation Software 510(k) No : K082478, Class 2, Product Code BZG. Manufacturer : MIR Device Name : Spirodoc 510(k) No : K103530, Class… | 2009 |
| * | K103530 | SpirodocSummary page 5…ect Workstation Software 510(k) No : K082478, Class 2, Product Code BZG. Manufacturer : MIR Device Name : Spirodoc 510(k) No : K103530, Class 2, Product Code BZG. 8. Description of Device: Spirotrac shall provide a secure PC based medical device software appli… | 2011 |
What descends from it? (2)
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 20 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K201562 (Vitalograph Ireland, Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 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. 2014, 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 Vitalograph Model 7000 Spirotrac is 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. The device is a PC based software application which is intended to be used as a spirometer or connect to compatible Vitalograph or third party devices to acquire, view, store and print the device output.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141546: Vitalograph Model 7000 Spirotrac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141546
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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