# K242485: EveryWare

- Pathway: 510(k) (Traditional)
- Applicant: Breas Medical AB
- Decided: May 20, 2025 after 272 days
- Product code: MOD (Accessory To Continuous Ventilator (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K971260 (1997). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151901: AirView, Resmed, Ltd. (2015) Summary page 5.
- K152356: Sapphire, Respironics, Inc. (2016) Summary page 5.

## Indications for use
EveryWare is indicated to support clinicians by managing data of patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. EveryWare provides remote patient data collection & viewing and is intended to be used by healthcare representatives in conjunction with compatible non-life support therapy devices to adjust prescription and/or performance settings. EveryWare is intended to be used in hospital, institutional, provider, and home care settings.

Source page: https://510kreport.com/device/K242485
Methodology: https://510kreport.com/methodology