# K183586: CapMedic

- Pathway: 510(k) (Traditional)
- Applicant: Cognita Labs, LLC
- Decided: Sep 13, 2019 after 266 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: 5 generations back to K823423 (1982). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 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 4.
- K140638: Propeller System - Model 2, Reciprocal Labs Corporation (2014) Summary page 4.
- K133722: Asthma Monitor AM3, Eresearch Technology (2014) Summary page 4.

## Indications for use
The CapMedic is intended to be used in adults and children 5 years of age and above, who are prescribed CapMedic to be used with their MDIs by their physician. The CapMedic device is an accessory intended for single-patient use to assist physicians and patients in recording and monitoring the MDI (Metered Dose Inhaler) actuations and conducting PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume for 1 second) spirometry tests. CapMedic measures the parameters of MDI use and records it for review by the physician and/or the patient. Furthermore, CapMedic reminds the patient on important steps of MDI use through audio-visual-haptic cues during their MDI use. With the provided PEF/FEV1 adapter, CapMedic can also perform PEF/FEV1 spirometry test and provides LED feedback based on the measured FEV1. CapMedic can securely transmit MDI usage data and PEF/FEV1 test results to a Bluetooth enabled device running data collection software meeting the CapMedic secure interface protocol over a Bluetooth connection. CapMedic can be used in the home, work, healthcare, and clinical use environments/settings. The CapMedic device may also be used in clinical trials where researchers need to know information about the use of MDI medication(s) by a participant. CapMedic may be used with any of the following MDIs: Ventolin HFA, ProAir HFA, Advair HFA, Flovent HFA, Xopenex HFA, Symbicort HFA, Atrovent HFA, Proventil HFA, Alvesco HFA, Dulera HFA, and Asmanex HFA and is attached with a specific adapter for the MDIs.

Source page: https://510kreport.com/device/K183586
Methodology: https://510kreport.com/methodology