# K163485: SmartTouch

- Pathway: 510(k) (Traditional)
- Applicant: Adherium (Nz), Ltd.
- Decided: Aug 30, 2017 after 261 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: 4 generations back to K823423 (1982). 7 ancestors in all.
6 later devices descend from it; 1 cites 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)
- K133951: Smarttouch, Nexus6, Ltd. (2014) Summary page 4.

## Most influential descendants
- K173310: SmartTouch (2018), 5 descendants of its own
- K211233: Hailie Sensor NF0109 (2021), 3 descendants of its own
- K222247: Hailie Sensor NF0110 (2023), 1 descendant of its own
- K250022: HeroTracker Sense (2025), 0 descendants of its own
- K220622: Hailie Sensor NF0106 (2022), 0 descendants of its own

## Indications for use
The SmartTouch is intended for single-patient use in the home environment as a medication reminder and 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 MDI medication. • In self-management, where patients need to track their medication use as part of their management plan. The SmartTouch is compatible only with the Symbicort MDI. 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/K163485
Methodology: https://510kreport.com/methodology