# K121747: Facefit and Facefit Ported Non-Invasive Ventilation Masks

- Pathway: 510(k) (Traditional)
- Applicant: Intersurgical Incorporated
- Decided: Mar 14, 2013 after 273 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: 5 generations back to K982530 (1998). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063011: Mirage Liberty Full Face Mask, Resmed, Ltd. (2007) Summary page 1.

## Indications for use
The FaceFit Ported Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system. This is a disposable mask. It is intended to be used for 24 hours of treatment of a single patient only, and then discarded. The masks are intended to be used in hospitals.

Source page: https://510kreport.com/device/K121747
Methodology: https://510kreport.com/methodology