# K052328: Zan Lung-Function Lab

- Pathway: 510(k) (Traditional)
- Applicant: Zan Messgerate GmbH
- Decided: Dec 22, 2005 after 119 days
- Product code: BZC (Calculator, Pulmonary Function Data)
- Device class: 2
- Regulation: 21 CFR 868.1880
- 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 K942211 (1994). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992743: Collins CPL, Collins Medical, Inc. (1999) Summary page 1.
- K942211: VMAX229 Series Pulmonary/Metabolic Systems, Sensor Medics Corp. (1994) Summary page 1.

## Most influential descendants
- K133051: Pulmone Minibox PFT TM (2014), 3 descendants of its own
- K141793: Pulmone Miniboxpft 2.0 (2015), 2 descendants of its own
- K161295: MiniBox + (2016), 1 descendant of its own
- K240293: STS (2024), 0 descendants of its own

## Indications for use
ZAN Lung-Function Lab is used to measure or monitor pulmonary function in adult and pediatric subjects during exercise (including diagnosis, training, and stress testing) or while at rest (including spirometry, airway strength and compliance, diffusion capacity, body plethysmography, nutritional assessment, and indirect cardiac output) for diagnosis, rehabilitation, performance enhancement, and other related activities.

Source page: https://510kreport.com/device/K052328
Methodology: https://510kreport.com/methodology