# K954759: Flowmate Lte

- Pathway: 510(k) (Traditional)
- Applicant: Spirometrics Medical Equipment Co.
- Decided: Apr 12, 1996 after 178 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 K863953 (1987). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- (no number) Flash Portable Spirometry System: named in the summary without a submission number

## Most influential descendants
- K982956: Flowmate II Plus, Model #4000 (1998), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K954759
Methodology: https://510kreport.com/methodology