Family of DIMAR DMAX NIV masks— 510(k) K232836

Name: FDA 510(k) clearance K232836
Creator: U.S. Food and Drug Administration
Published: 2024-08-14

Substantially Equivalent

Dimar S.P.A.

FDA 510(k) clearance K232836 for Family of DIMAR DMAX NIV masks, Substantially Equivalent on 2024-08-14. Applicant: Dimar S.P.A.. Device class: 2.

Clearance details

Applicant: Dimar S.P.A.
Product code: Code CBK
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 2023-09-14
Decision date: 2024-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medolla, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code CBK

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K253647 — Evita (V800); Evita (V600)2026-05-07
K252663 — Inbentus Versatile2026-04-14
K251888 — VPAP Pediatric Face Mask2026-03-12
K232365 — Vivo 45 LS2025-12-19
K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A) +3 more2025-09-10

Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.