510(k) · Cleared
ClearedSpiro-Master PC-10 Spirometry System
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 Jan 21, 2009 as substantially equivalent to K020102 (Iqteq Development, 2003) and 1 other predicate after a 295-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Jan 21, 2009
- Review
- 295 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K002499 (2000). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK002499 Brentwood Iqmark Digital Spirometer (Includes Disposable Pneumotach…Brentwood Medical Technology Corp. · 2000
- This deviceK080921 Spiro-Master PC-10 Spirometry SystemChest M.I., Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002499 | Brentwood Iqmark Digital Spirometer (Includes Disposable Pneumotach… | Brentwood Medical Technology Corp. | 2000 | — |
| 0 (this device) | K080921 | Spiro-Master PC-10 Spirometry System | Chest M.I., Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 |
|---|---|---|---|
| * | K020102 | Iqteq SpirometerSummary page 1…icate devices The Spiro-Master PC-10 Spirometry System is substantially equivalent to the following legally marketed devices 510(k) k020102 Trade name IQTeQ Spirometer 2001 Product code BZG 510(k) k002499… | 2003 |
| * | K002499 | Brentwood Iqmark Digital Spirometer (Includes Disposable Pneumotach Mouthpieces and…Summary page 1…keted devices 510(k) k020102 Trade name IQTeQ Spirometer 2001 Product code BZG 510(k) k002499 Trade name Brentwood IQMarkTM Digital Spirometer Product code BZG / SPIRO-MASTER PC-… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 2 ancestors has a recall.
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 Spiro-Master PC-10 Spirometry System is indicated for use with people of all ages, of either gender, excluding infants and neonates, to acquire, view, store and print measures and waveforms of the exhaled breath of a person and evaluate, access, describe, measure, or monitor 1 Symptoms, signs, or abnormal laboratory tests 2 Effects of disease on pulmonary function 3 Individuals at risk for pulmonary disease 4 Preoperative risk 5 Post-surgical…
Read the full statement (124 words)
The Spiro-Master PC-10 Spirometry System is indicated for use with people of all ages, of either gender, excluding infants and neonates, to acquire, view, store and print measures and waveforms of the exhaled breath of a person and evaluate, access, describe, measure, or monitor
1 Symptoms, signs, or abnormal laboratory tests
2 Effects of disease on pulmonary function
3 Individuals at risk for pulmonary disease
4 Preoperative risk
5 Post-surgical prognosis
6 Pre-treatment health status
7 Therapeutic interventions
8 The course of disease affecting lung function
9 Persons exposed to pollutants
10 Adverse reactions to drugs with known pulmonary toxicity
11 Rehabilitation programs
12 Risks as part of an insurance evaluation
13 Individuals for legal reasons
14 Epidemiological surveys
15 Derivation of reference equations
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K080921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080921: Spiro-Master PC-10 Spirometry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080921
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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