510(k) · Cleared
ClearedCardiotech Spirometry System, Model GT-105
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chest M.I., Inc. · BZG Spirometer, Diagnostic
Cleared on Jul 23, 2009 as substantially equivalent to K022103 (Puritan Bennett Corp., 2002) and 1 other predicate after a 134-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Jul 23, 2009
- Review
- 134 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K944762 (1994). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK944762 Puritan-Bennett Renaissance Spirometry Systemwith the…Puritan Bennett Corp. · 1994
- 1 generation backK022103 Puritan-Bennett 700 Renaissance II Spirometry SystemPuritan Bennett Corp. · 2002
- This deviceK090646 Cardiotech Spirometry System, Model GT-105Chest M.I., Inc. · 2009
- Descendant · cites it directly · 0 of its ownK201493 SpirometerMehow Innovative, Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K201493SpirometerMehow Innovative, Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944762 | Puritan-Bennett Renaissance Spirometry Systemwith the Optionalrenaissance DB… | Puritan Bennett Corp. | 1994 | — |
| −1 | K022103 | Puritan-Bennett 700 Renaissance II Spirometry System | Puritan Bennett Corp. | 2002 | — |
| 0 (this device) | K090646 | Cardiotech Spirometry System, Model GT-105 | Chest M.I., Inc. | 2009 | — |
| +1 | K201493 | Spirometer | Mehow Innovative, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K022103 | Puritan-Bennett 700 Renaissance II Spirometry SystemSummary page 1…BZG Classification: II Panel: Anesthesiology 3. Predicate Devices The CardioTech Spirometer issubstantially equivalent to the following devices: K022103 PB700 Renaissance 11Spirometry System Puritan Bennett Inc. K031102 Microlab Spi… | 2002 |
| * | K031102 | Microlab SpirometerSummary page 1…rometer issubstantially equivalent to the following devices: K022103 PB700 Renaissance 11Spirometry System Puritan Bennett Inc. K031102 Microlab Spirometer Micro Direct, Inc. 4. Indications for Use The CardioTech Spir… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201493 | Spirometer | 2021 | 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?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 7.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K201493 (Mehow Innovative, Ltd., 2021) has gone furthest, with 0 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. 2009, 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 CardioTech Spirometry System, Model GT-105, is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician's offices, laboratories, and occupational health environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090646: Cardiotech Spirometry System, Model GT-105.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090646
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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