# K080921: Spiro-Master PC-10 Spirometry System

- Pathway: 510(k) (Traditional)
- Applicant: Chest M.I., Inc.
- Decided: Jan 21, 2009 after 295 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
Longest line of descent: 1 generation back to K002499 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020102: Iqteq Spirometer, Iqteq Development (2003) Summary page 1.
- K002499: Brentwood Iqmark Digital Spirometer (Includes Disposable Pneumotach Mouthpieces and 3-Liter Calibration Syringe, Brentwood Medical Technology Corp. (2000) Summary page 1.

## Indications for use
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

Source page: https://510kreport.com/device/K080921
Methodology: https://510kreport.com/methodology