Cleared Traditional

K242485 - EveryWare

K242485 is an FDA 510(k) clearance for EveryWare, manufactured by Breas Medical AB. The device is a Class 2 Anesthesiology device with product code MOD cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K242485 · Breas Medical AB · Anesthesiology device
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May 2025
Decision
272d
Days
Class 2
Risk

K242485 is an FDA 510(k) clearance for the EveryWare. Classified as Accessory To Continuous Ventilator (respirator) (product code MOD), Class II - Special Controls.

Submitted by Breas Medical AB (Molnlycke, SE). The FDA issued a Cleared decision on May 20, 2025 after a review of 272 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Breas Medical AB devices

FDA 510(k) Submission Details - K242485

510(k) Number K242485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2024
Decision Date May 20, 2025
Days to Decision 272 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 140d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOD Device Classification - Class 2, Special Controls

Product Code MOD Accessory To Continuous Ventilator (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - MOD Accessory To Continuous Ventilator (respirator)

Devices cleared under the same product code (MOD) and FDA review panel - the closest regulatory comparables to K242485.
CorVision® (91-205-Z0014)
K260051 · Corvent Medical, Inc. · May 2026
Care Cycle Connect Application
K161411 · Respironics, Inc. · Feb 2017
IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00
K022062 · Impact Instrumentation, Inc. · May 2003
VENTNET
K963633 · Puritan Bennett Corp. · Dec 1996