# K013812: Spirolab II, Model 29

- Pathway: 510(k) (Traditional)
- Applicant: Sdi Diagnostics, Inc.
- Decided: Feb 11, 2002 after 88 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.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices 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.

## Most influential descendants
- K052140: Spirolab, Spirolab II (2006), 7 descendants of its own
- K082766: Modification to Minispir, Spirolab Iii (2008), 5 descendants of its own
- K122384: Minispir (2012), 4 descendants of its own
- K133051: Pulmone Minibox PFT TM (2014), 3 descendants of its own
- K141793: Pulmone Miniboxpft 2.0 (2015), 2 descendants of its own

## Indications for use
The Spirolab II Spirometer is intended to be used by a physician or respiratory therapist or technician to test lung function in people of all ages. It can be used in any setting, home, factory hospital or physician’s office.

Source page: https://510kreport.com/device/K013812
Methodology: https://510kreport.com/methodology