# K031643: Spirotel, Model 29-1020

- Pathway: 510(k) (Traditional)
- Applicant: Sdi Diagnostics, Inc.
- Decided: Dec 9, 2003 after 196 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.
44 later devices descend from it; 2 cite it directly.
0 of 45 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
- K043528: Spirotel (2005), 42 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K031643
Methodology: https://510kreport.com/methodology