# K060067: Maskmedic Concept Nasal Mask

- Pathway: 510(k) (Traditional)
- Applicant: Maskmedic
- Decided: Jul 14, 2006 after 186 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961783 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030798: Mirage Activa Mask, Resmed, Ltd. (2003) Summary page 1.

## Indications for use
The Maskmedic Concept Nasal Mask is indicated for use as an accessory nasal mask with standard Continuous Positive Airway Pressure (CPAP) and bi-level positive airway treatment devices and other non continuous ventilators. The mask is suitable for use in medical facilities or for patient home use. It is intended for single patient/multi-use

Source page: https://510kreport.com/device/K060067
Methodology: https://510kreport.com/methodology