# K043528: Spirotel

- Pathway: 510(k) (Traditional)
- Applicant: Mir Medical Intl. Research Srl
- Decided: Jul 19, 2005 after 210 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 K943404 (1994). 6 ancestors in all.
42 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031643: Spirotel, Model 29-1020, Sdi Diagnostics, Inc. (2003) Summary page 1.
- K013171: 3420 Digit Pulse Oximeter, Model 3420, Bci, Inc. (2002) Summary page 1.

## Most influential descendants
- K061712: Spirobank II (2006), 40 descendants of its own
- K072979: Spirobank G (2007), 33 descendants of its own
- K191272: Wearable Device, Wearable Package (2019), 16 descendants of its own
- K210133: Current Health Monitoring System Gen 2 (G2) (2021), 8 descendants of its own
- K221282: Empatica Health Monitoring Platform (2022), 7 descendants of its own

## Indications for use
The Spirotel spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic to test lung function in people of all ages. It is also intended to be used as a single-patient device and can be used in any setting - home, factory, pharmacy, hospital or physician's office.

Source page: https://510kreport.com/device/K043528
Methodology: https://510kreport.com/methodology