# K103530: Spirodoc

- Pathway: 510(k) (Traditional)
- Applicant: Medical International Research USA, Inc.
- Decided: Nov 21, 2011 after 355 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: 4 generations back to K943404 (1994). 9 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061712: Spirobank II, Mir Medical Intl. Research Srl (2006) Summary page 1.

## Most influential descendants
- K141546: Vitalograph Model 7000 Spirotrac (2014), 2 descendants of its own
- K230501: Spirobank Oxi (2023), 0 descendants of its own
- K201562: Spirotrac (2020), 0 descendants of its own
- K142642: Vitalograph Model 6600 Compact (2015), 0 descendants of its own

## Indications for use
The Spirodoc Spirometer and pulse oximeter is intended to be used by a physician or by a patient under the prescribed use of a physician. The device is intended to test lung function and can perform spirometry testing in adult and pediatric patients, excluding infants and neonates, and oximetry readings in patients of all ages.

Source page: https://510kreport.com/device/K103530
Methodology: https://510kreport.com/methodology