# K133951: Smarttouch

- Pathway: 510(k) (Traditional)
- Applicant: Nexus6, Ltd.
- Decided: Apr 25, 2014 after 123 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: 3 generations back to K823423 (1982). 6 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091803: Smarttrack System, Nexus6, Ltd. (2009) Summary page 1.

## Most influential descendants
- K163485: SmartTouch (2017), 6 descendants of its own
- K173310: SmartTouch (2018), 5 descendants of its own
- K180407: Smartinhaler (2018), 4 descendants of its own
- K211233: Hailie Sensor NF0109 (2021), 3 descendants of its own
- K222247: Hailie Sensor NF0110 (2023), 1 descendant of its own

## Indications for use
The SmartTouch is intended for single-patient use as an electronic data capture accessory for recording 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, nurses, and educators need to know if a patient has actuated their prescribed MVDI medication. * In self-management, where patients need to track their medication use as part of their management plan. The SmartTouch 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/K133951
Methodology: https://510kreport.com/methodology