# K232836: Family of DIMAR DMAX NIV masks

- Pathway: 510(k) (Traditional)
- Applicant: Dimar S.P.A.
- Decided: Aug 14, 2024 after 335 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K925920 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072588: Performax SE Total Face Mask, Respironics Inc., Sleep & Home Respiratory Group (2007) Summary page 5.
- K992969: Respironics Total Face Mask, Respironics, Inc. (1999) Summary page 5.

## Indications for use
FAMILY OF DIMAR DIMAX NIV MASKS is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency. For single patient use in the Hospital environment The mask is to be used on patients who are appropriate candidates for noninvasive ventilation. The small size is intended to be used for children (from 7 years and > 20kg) while the sizes medium/large/ extra-large/ extra-extra-large are intended to be used for adolescents or adults >30 kg

Source page: https://510kreport.com/device/K232836
Methodology: https://510kreport.com/methodology