510(k) · Cleared
ClearedIqteq Spirometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iqteq Development · BZG Spirometer, Diagnostic
Cleared on Mar 21, 2003 after a 434-day review. The summary cites 2 numbers, none of which could be confirmed as its predicate (see the table below). 1 later device descends from it.
- Decided
- Mar 21, 2003
- Review
- 434 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 2
1 later device descends from it, 1 citing it directly.
- This deviceK020102 Iqteq SpirometerIqteq Development · 2003
- Descendant · cites it directly · 0 of its ownK080921 Spiro-Master PC-10 Spirometry SystemChest M.I., Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K080921Spiro-Master PC-10 Spirometry SystemChest M.I., Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020102 | Iqteq Spirometer | Iqteq Development | 2003 | — |
| +1 | K080921 | Spiro-Master PC-10 Spirometry System | Chest M.I., Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K000673 | FDA’s K000673 is Hysteroscope Operating Sheath and Insert, Model 8988.031/.041/.231/.241 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2000 |
| Kept off the family tree | K020499 | FDA’s K020499 is Bond-3 Adhesive Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2002 |
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 |
|---|---|---|---|
| K080921 | Spiro-Master PC-10 Spirometry System | 2009 | 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, K080921 (Chest M.I., Inc., 2009) 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.
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 IQTeQ Spirometer is intended for use as a prescription-use-only clinical diagnostic spirometer for pulmonary function evaluation and data management. The IQTeQ Spirometer is for use in hospitals, clinics and physician/clinician offices by individuals that have received minimal instruction or training in the administration of spirometry tests. The IQTeQ Spirometer operates with an IBM or compatible computer using a USB port (Universal serial bus)…
Read the full statement (189 words)
The IQTeQ Spirometer is intended for use as a prescription-use-only clinical diagnostic spirometer for pulmonary function evaluation and data management.
The IQTeQ Spirometer is for use in hospitals, clinics and physician/clinician offices by individuals that have received minimal instruction or training in the administration of spirometry tests. The IQTeQ Spirometer operates with an IBM or compatible computer using a USB port (Universal serial bus) connection and the PC's installed IQTeQ Spirometer WindowsTM compatible software. Minimum PC and operating system requirements are specified in the IQTeQ Spirometer Manual.
The IQTeQ Spirometer is indicated for use with male/female adult patients and male/female pediatric patients to 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 as stated in the FDA summary.
https://510kreport.com/device/K020102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020102: Iqteq Spirometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020102
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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