FDA 510(k)

EveryWare

K-Number: K242485 · 2025-05-20

Decision Date2025-05-20

Product CodeMOD

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

EveryWare is the device name listed in this FDA 510(k) record. The listed applicant is Breas Medical AB. It received FDA 510(k) clearance on 2025-05-20 under 510(k) number K242485. The device is classified under product code MOD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EveryWare?

EveryWare is a medical device that received FDA 510(k) clearance on 2025-05-20. The listed applicant is Breas Medical AB. The 510(k) number is K242485.

When did EveryWare receive FDA 510(k) clearance?

EveryWare received FDA 510(k) clearance on 2025-05-20, under 510(k) number K242485.

Who is the listed applicant for EveryWare?

The FDA 510(k) record lists Breas Medical AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EveryWare?

The FDA product code for EveryWare is MOD.

Other records listing Breas Medical AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242438Clearo K233452Vivo 45 LS K240779Vivo 3 K240778Vivo 1, Vivo 2 K193586Vivo 45 LS K160481Vivo 60

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Related Devices (Code: MOD)

K260051CorVision® (91-205-Z0014)CorVent® Medical, Inc.K161411Care Cycle Connect ApplicationRespironics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.