Cleared Traditional

Family of DIMAR DMAX NIV masks (K232836) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232836 · Dimar S.P.A. · Anesthesiology device
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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

Submission Details

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.

Device Classification

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 106
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
K241135 · Corvent Medical, Inc. · Nov 2024
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
Nihon Kohden NKV-550 Series Ventilator System
K231778 · Nihon Kohden Orangemed, LLC · Mar 2024