# K982956: Flowmate II Plus, Model #4000

- Pathway: 510(k) (Traditional)
- Applicant: Spirometrics Medical Equipment Co.
- Decided: Nov 24, 1998 after 92 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: 2 generations back to K863953 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954759: Flowmate Lte, Spirometrics Medical Equipment Co. (1996) Summary page 1.
- K863953: Spirometrics Model 2500 Flowmate (TM), Spirometrics, Inc. (1987) Summary page 1.
- K900673: Serial Flow, Spirometrics, Inc. (1990) Summary page 1.
- K911143: PB100 Diagnostic Spirometer, Puritan Bennett Corp. (1991) Summary page 1.
- K894997: Presto Diagnostic Spirometer, Tamarac Systems Corp. (1989) Summary page 1.

## Indications for use
Pulmonary Function Testing Diagnostic To evaluate symptoms, signs, or abnormal laboratory tests - Symptoms: dyspnea, wheezing, orthopnea, cough, phlegm production, chest pain - Signs: diminished breath sounds, overinflation, expiratory slowing, cyanosis, chest deformity, unexplained crackles - Abnormal laboratory tests: hypoxemia, hypercapnia, polycythemia, abnormal chest radiographs To measure the effects of disease on pulmonary function Pulmonary Function Testing - continued Diagnostic - continued To screen individuals at risk of having pulmonary diseases - Smokers - Individuals in occupations with exposures to injurious substances - Some routine physical examinations To assess preoperative risk To assess prognosis (lung transplant, etc.) To assess health status before enroliment in strenuous phsical activity programs Monitoring To assess therapeutic interventions - Bronchodilator therapy - Steroid treatment for asthma, interstitial lung disease, etc. - Management of congestive heart failure - Other (antibiotics in cystic fibrosis, etc.) To describe the course of diseases affecting lung function - Pulmonary diseases Obstructive airways diseases Interstitial lung diseases - Cardiac diseases Congestive heart failure - Neuromuscular diseases Guillain-Barré To monitor persons in occupations with exposure to injurious agents To monitor for adverse reactions to drugs with known pulmonary toxicity Disability / Impairment Evaluations To assess patients as part of a rehabilitation program - Medical - Industrial - Vocational To assess risks as part of an insurance evaluation To assess individuals for legal reasons - Social Security or other government compensation programs - Personal injury lawsuits - Others Pulmonary Function Testing - continued Public Health Epidemiologic surveys - Comparison of health status of populations living in different environments - Validation of subjective complaints in occupational / environmental settings Derivation of reference equations

Source page: https://510kreport.com/device/K982956
Methodology: https://510kreport.com/methodology