# K052140: Spirolab, Spirolab II

- Pathway: 510(k) (Traditional)
- Applicant: Mir Medical Intl. Research Srl
- Decided: Mar 16, 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: 1 generation back to K013812 (2002). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013812: Spirolab II, Model 29, Sdi Diagnostics, Inc. (2002). Our reading of the summary gave K012812, FDA’s number for Carotid Guiding Sheath (Terumo Medical Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SDI Spirolab II”.

## Most influential descendants
- 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
- K161295: MiniBox + (2016), 1 descendant of its own

## Indications for use
The Spirolab and Spirolab II spirometers are intended to be used by either a physician, respiratory therapist or technician to test lung function in people of all ages excluding infants and neonates. They can be used in any setting.

Source page: https://510kreport.com/device/K052140
Methodology: https://510kreport.com/methodology