510(k) · Cleared
ClearedFlowmate II Plus, Model #4000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spirometrics Medical Equipment Co. · BZG Spirometer, Diagnostic
Cleared on Nov 24, 1998 as substantially equivalent to K954759 (Spirometrics Medical Equipment Co., 1996) and 4 other predicates after a 92-day review. Its family tree reaches back 2 generations to 1987.
- Decided
- Nov 24, 1998
- Review
- 92 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K863953 (1987). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K863953 | Spirometrics Model 2500 Flowmate (TM) | Spirometrics, Inc. | 1987 | — |
| −1 | K954759 | Flowmate Lte | Spirometrics Medical Equipment Co. | 1996 | — |
| 0 (this device) | K982956 | Flowmate II Plus, Model #4000 | Spirometrics Medical Equipment Co. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 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? (5)
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 |
|---|---|---|---|
| * | K954759 | Flowmate LteSummary page 1…umotachs with models Flowmate, Flowmate LTE, and PC Flow + devices. This listed product is substantially equivalent to the Flowmate 2500LTE premarket notification number K954759, Flowmate 2500 premarket notification number K863953/A, and PC Flow + 3350 premarket notification number K900673 manufactured by… | 1996 |
| * | K863953 | Spirometrics Model 2500 Flowmate (TM)Summary page 1…low + devices. This listed product is substantially equivalent to the Flowmate 2500LTE premarket notification number K954759, Flowmate 2500 premarket notification number K863953/A, and PC Flow + 3350 premarket notification number K900673 manufactured by Spirometrics, the Renaissance from Puritan Bennett pr… | 1987 |
| * | K900673 | Serial FlowSummary page 1…nt to the Flowmate 2500LTE premarket notification number K954759, Flowmate 2500 premarket notification number K863953/A, and PC Flow + 3350 premarket notification number K900673 manufactured by Spirometrics, the Renaissance from Puritan Bennett premarket notification number K911143, and the Presto Flash Po… | 1990 |
| * | K911143 | PB100 Diagnostic SpirometerSummary page 1…mber K863953/A, and PC Flow + 3350 premarket notification number K900673 manufactured by Spirometrics, the Renaissance from Puritan Bennett premarket notification number K911143, and the Presto Flash Portable Spirometry System from Burdick Inc. premarket notification number K894997. For a description of t… | 1991 |
| * | K894997 | Presto Diagnostic SpirometerSummary page 1…e Renaissance from Puritan Bennett premarket notification number K911143, and the Presto Flash Portable Spirometry System from Burdick Inc. premarket notification number K894997. For a description of the device see Summary Exhibit 1. Description of the device: . Flow sensing pneumotach and base that meas… | 1989 |
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 9.2 years on median.
- None of the 5 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.
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?
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…
Read the full statement (269 words)
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
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/K982956 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982956: Flowmate II Plus, Model #4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982956
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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