# K130686: Nasal Comfort Freedom

- Pathway: 510(k) (Traditional)
- Applicant: Lakeview Sleep Center
- Decided: Oct 16, 2013 after 217 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: 6 generations back to K982530 (1998). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090244: Swift FX, Resmed, Ltd. (2009) Summary page 2.
- K102502: Golife Nasal Mask, Respironics, Inc. (2010) Summary page 2.

## Indications for use
The Nasal Comfort Freedom provides a conduit such that airflow from a positive pressure source is directed to a patients nose. The device Is intended for adult patients (>66 lb/30kg) for whom positive airway pressure has been prescribed. The device is single-patient re-use, and is intended for use in a clinical or home-use environment.

Source page: https://510kreport.com/device/K130686
Methodology: https://510kreport.com/methodology