# K973456: Spirobank Portable PC Based Spirometer

- Pathway: 510(k) (Traditional)
- Applicant: Futuremed America, Inc.
- Decided: Jul 22, 1998 after 314 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Spirobank can carry out the FVC, VC & IVC, MVYV and respiratory profile tests, measuring more than 20 functional parameters, and also calculate repeatability and test acceptability indices. The functional automatic diagnosis consists of an 11 scale classification, as laid down in the ATS recommendations. The tests can be performed in adults and pediatrics, in the hospital, clinic and at home. Results are displayed on the LCD display of the device, and printed on an external printer, transferred to a PC. Memory bank of the device can store several hundred test results which may be transferred to a PC, printed on an external printer, or reviewed on the device at a later date.

Source page: https://510kreport.com/device/K973456
Methodology: https://510kreport.com/methodology