# K121609: Asthmapolis System

- Pathway: 510(k) (Traditional)
- Applicant: Reciprocal Labs Corporation
- Decided: Jul 2, 2012 after 31 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.
13 later devices descend from it; 1 cites it directly.
0 of 20 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
- K140638: Propeller System - Model 2 (2014), 12 descendants of its own
- K142516: Propeller System (2015), 8 descendants of its own
- K143671: Propeller Model 2014-D Sensor (2015), 4 descendants of its own
- K152882: Propeller System (2016), 3 descendants of its own
- K161454: Propeller Sensor Model 2015-E (2016), 2 descendants of its own

## Indications for use
The Asthmapolis System includes the Asthmapolis Sensor which is an electronic accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage. The Asthmapolis Mobile Application records, stores, and transmits usage events from the Asthmapolis Sensor to a remote storage system. The Asthmapolis Web Application is software intended to allow users to review the collected information and characteristics of MDI use, to add detail associated with a recorded usage event, and to share that information with their physician in order to provide additional information associated with the condition for which their MIDI medication(s) are prescribed. The Asthniapolis System may also be used in clinical trials where researchers need to know information about use of a MDI Medication(s) by a participant. The output of the Asthmapolis System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The Asthmapolis 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.

Source page: https://510kreport.com/device/K121609
Methodology: https://510kreport.com/methodology