# K073155: Vitalograph Model 4000 (Asma-1 and Copd-6)

- Pathway: 510(k) (Traditional)
- Applicant: Vitalograph (Ireland), Ltd.
- Decided: Jun 4, 2008 after 209 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: 3 generations back to K901057 (1990). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061283: Pulmolife, Micro Medical, Ltd. (2006) Summary page 1.

## Most influential descendants
- K241843: TD-7301 Spirometer (TD-7301) (2024), 0 descendants of its own
- K103575: Spiro PD (2011), 0 descendants of its own

## Indications for use
To be used by the asthma / copd patient at home to monitor the condition. To be used in General Practitioner's clinic with disposable mouthpieces. The Model 4000 range is intended as to compete directly with competitor's electronic peak flow meters and COPD screening devices.

Source page: https://510kreport.com/device/K073155
Methodology: https://510kreport.com/methodology