# K061099: Breathx Nasal Pillow and Mask System, Model 011-0003

- Pathway: 510(k) (Traditional)
- Applicant: Hoffman Laboratories, LLC
- Decided: Aug 11, 2006 after 114 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). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031883: Lyra Nasal Mask, Sensor Medics Corp. (2003) Summary page 1.
- K050359: Ultra Mirage II Mask, Resmed, Ltd. (2005) Summary page 1.

## Indications for use
The BreatheX Nasal Interface System is an accessory intended for use with devices that deliver Continuous Positive Airway Pressure (CPAP) and bi-level positive airway pressure in treating adult patients.

Source page: https://510kreport.com/device/K061099
Methodology: https://510kreport.com/methodology