# K061283: Pulmolife

- Pathway: 510(k) (Traditional)
- Applicant: Micro Medical, Ltd.
- Decided: Dec 14, 2006 after 220 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: 2 generations back to K901057 (1990). 2 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K963035: Micro Spirometer, Micro Direct, Inc. (1996) Summary page 1.

## Most influential descendants
- K073155: Vitalograph Model 4000 (Asma-1 and Copd-6) (2008), 2 descendants of its own
- K241843: TD-7301 Spirometer (TD-7301) (2024), 0 descendants of its own
- K103575: Spiro PD (2011), 0 descendants of its own

## Indications for use
The device measures expiratory lung function parameters, specifically FEVI and conforms to ATS standards for diagnostic devices. The results obtained can be used for screening of COPD in adult smokers.

Source page: https://510kreport.com/device/K061283
Methodology: https://510kreport.com/methodology