# K020102: Iqteq Spirometer

- Pathway: 510(k) (Traditional)
- Applicant: Iqteq Development
- Decided: Mar 21, 2003 after 434 days
- Product code: BZG (Spirometer, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 868.1840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K000673: Hysteroscope Operating Sheath and Insert, Model 8988.031/.041/.231/.241, Richard Wolf Medical Instruments Corp. (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K020499: Bond-3 Adhesive, Jeneric/Pentron, Inc. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K080921: Spiro-Master PC-10 Spirometry System (2009), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K020102
Methodology: https://510kreport.com/methodology