510(k) · Cleared
ClearedFlowmate Lte
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 Apr 12, 1996 as substantially equivalent to K863953 (Spirometrics, Inc., 1987) and 2 other predicates after a 178-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.
- Decided
- Apr 12, 1996
- Review
- 178 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K863953 (1987). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K982956Flowmate II Plus, Model #4000Spirometrics Medical Equipment Co. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K863953 | Spirometrics Model 2500 Flowmate (TM) | Spirometrics, Inc. | 1987 | — |
| 0 (this device) | K954759 | Flowmate Lte | Spirometrics Medical Equipment Co. | 1996 | — |
| +1 | K982956 | Flowmate II Plus, Model #4000 | Spirometrics Medical Equipment Co. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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? (4)
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 |
|---|---|---|---|
| * | K863953 | Spirometrics Model 2500 Flowmate (TM)Summary page 1…ing a flow sensing pneumotach with its models Fiowmate and PC Flow +. The proposed product is substantially equivalent to the Flowmate 2500 premarket notification number K863953/A, and PC Flow + 3350 premarket notification number K900673 both manufactured by Spirometrics, the Renaissance from Puritan Benne… | 1987 |
| * | K900673 | Serial FlowSummary page 1…C Flow +. The proposed product is substantially equivalent to the Flowmate 2500 premarket notification number K863953/A, and PC Flow + 3350 premarket notification number K900673 both manufactured by Spirometrics, the Renaissance from Puritan Bennett premarket notification number K911143, and the Flash Port… | 1990 |
| * | K911143 | PB100 Diagnostic SpirometerSummary page 1…K863953/A, and PC Flow + 3350 premarket notification number K900673 both manufactured by Spirometrics, the Renaissance from Puritan Bennett premarket notification number K911143, and the Flash Portable Spirometry System from Tamarac Systems Corporation premarket notification number unkown. For a descripti… | 1991 |
| * | — | Flash Portable Spirometry System Named without a submission number |
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 |
|---|---|---|---|
| K982956 | Flowmate II Plus, Model #4000 | 1998 | 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?
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?
Intended use for the Flowmate LTE is for Pulmonary Function Testing (measuring a person's ability to move air into and out of their lungs). The volume and flow rates measured for the entire effort and then reported as numerical results with a printout of the effort if selected.
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/K954759 · printed Nov 5, 2026
Cite this page
510(k) Report. “K954759: Flowmate Lte.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954759
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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