Cleared Traditional

K232836 - Family of DIMAR DMAX NIV masks

K232836 is an FDA 510(k) clearance for Family of DIMAR DMAX NIV masks, manufactured by Dimar S.P.A.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K232836 · Dimar S.P.A. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Aug 2024
Decision
335d
Days
Class 2
Risk

K232836 is an FDA 510(k) clearance for the Family of DIMAR DMAX NIV masks. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Dimar S.P.A. (Medolla, IT). The FDA issued a Cleared decision on August 14, 2024 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Dimar S.P.A. devices

FDA 510(k) Submission Details - K232836

510(k) Number K232836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2023
Decision Date August 14, 2024
Days to Decision 335 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 140d · This submission: 335d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
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 - CBK Ventilator, Continuous, Facility Use

All 261
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K232836.
Ventoux VC2
K223120 · Flight Medical Innovations , Ltd. · Dec 2024
RESPOND(R) Ventilator
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Mojo Full Face Non-Vented Mask
K241943 · Sleepnet Corporation · Aug 2024
VM-2000
K240807 · Ventis Medical, Inc. · Aug 2024
Mojo 2 Full Face Non-Vented Mask
K241520 · Sleepnet Corporation · Jun 2024
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K231778 · Nihon Kohden Orangemed, LLC · Mar 2024