# K052176: Flowhandy ZAN100 Usb

- Pathway: 510(k) (Traditional)
- Applicant: Zan Messgerate GmbH
- Decided: Jan 12, 2006 after 155 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 K933839 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933839: Master Screen Pnuemo, Erich Jaeger, Inc. (1994) Summary page 1.

## Indications for use
The Flowhandy ZAN100 USB is an open, personal-computer-based spirometry system with optional shutter for measuring and analyzing breath flow, volume, and pressure in adult and pediatric subjects for use by pulmonologists, allergists, general practitioners, and occupational-medicine practitioners in lung-function diagnosis.

Source page: https://510kreport.com/device/K052176
Methodology: https://510kreport.com/methodology