# K203155: BreatheSuite MDI V1

- Pathway: 510(k) (Traditional)
- Applicant: Breathesuite, Inc.
- Decided: Sep 17, 2021 after 330 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: 6 generations back to K823423 (1982). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142516: Propeller System, Reciprocal Labs Corporation (2015) Summary page 4.

## Indications for use
The BreatheSuite MDI Device is an electronic device intended for single-patient use of patients 5 years of age and older. It assists patients in recording and monitoring the actuations and technique of prescribed metered dose inhaler (MDI) usage. The BreatheSuite System is composed of the disposable, battery powered, portable BreatheSuite MDI Device and a mobile application. The BreatheSuite MDI Device is an accessory designed to work with an MDI by attaching to the top of the canister of the inhaler. The BreatheSuite MDI Device does not interfere with regular MDI usage and can be removed and reattached with ease. The BreatheSuite MDI Device does not actuate the inhaler but rather gathers information based on manual MDI usage. The BreatheSuite MDI Device measures the parameters of MDI use and records them for review by the patient. The BreatheSuite application records, stores, and transmits usage events from the BreatheSuite MDI Device to a remote storage system. Furthermore, BreatheSuite MDI reminds the patient of important steps of MDI use through visual feedback in the BreatheSuite application. The output of the BreatheSuite System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The BreatheSuite system is not intended for use as a MDI medication dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI. The BreatheSuite MDI Device is not intended to replace a physician's advice or inhaler labels; patients are expected to always follow their doctor's advice and inhaler labels. The BreatheSuite System can be used both indoors and outdoors as well as in home and work settings. The BreatheSuite System may also be used in clinical trials where researchers need to know information about use of a MDI Medication(s) by a participant.

Source page: https://510kreport.com/device/K203155
Methodology: https://510kreport.com/methodology