# K130663: BESTFIT2 Nasal Mask

- Pathway: 510(k) (Traditional)
- Applicant: Curative Medical, Inc.
- Decided: Sep 27, 2013 after 199 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: 4 generations back to K982530 (1998). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050359: Ultra Mirage II Mask, Resmed, Ltd. (2005) Summary page 1.

## Indications for use
The BestFit and BestFit 2 Nasal Masks are intended for multiple use on adult patients (body weight >30kg) prescribed with using continuous positive airway pressure (CPAP) or bi-level ventilator system in hospital, clinic and/or home environment.

Source page: https://510kreport.com/device/K130663
Methodology: https://510kreport.com/methodology