# K091803: Smarttrack System

- Pathway: 510(k) (Traditional)
- Applicant: Nexus6, Ltd.
- Decided: Oct 9, 2009 after 115 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- 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 K823423 (1982). 5 ancestors in all.
25 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990185: Mdilog, Model MDC-512, Medtrak Technologies, Inc. (1999) Summary page 1.
- K970344: Mdilog, Model MDC-511, Medtrak Technologies, Inc. (1997) Summary page 1.
- K935955: DOSER, Newmed Corp. (1994) Summary page 1.

## Most influential descendants
- K121609: Asthmapolis System (2012), 13 descendants of its own
- K140638: Propeller System - Model 2 (2014), 12 descendants of its own
- K133951: Smarttouch (2014), 10 descendants of its own
- K142516: Propeller System (2015), 8 descendants of its own
- K163485: SmartTouch (2017), 6 descendants of its own

## Indications for use
The SmartTrack System is intended for single-patient use as an electronic data capture accessory for recording and monitoring actuations of prescribed MDI usage. This may be used in the foLlowing applications: · In clinical trials, where researchers need to know when a patient has actuated their trial MDI medication; · In clinical practice, where specialists, general practitioners, and nurse educators need to know if a patient has actuated their prescribed MDI medication. The SmartTrack is not intended to indicate remaining quantity of medication in an MDI and does not include a dose counting function.

Source page: https://510kreport.com/device/K091803
Methodology: https://510kreport.com/methodology