# K131901: Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N2

- Pathway: 510(k) (Traditional)
- Applicant: 3B Medical, Inc.
- Decided: Dec 23, 2013 after 181 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: 7 generations back to K952292 (1995). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 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.
- K113127: Mirage Quattro, Resmed, Ltd. (2012) Summary page 2.
- K112271: 3B Willow, 3B Products, LLC (2012) Summary page 2.

## Indications for use
The iVolve® Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system. The iVolve® Mask is: 1. to be used by adult patients (>66 lb/30 kg) for whom positive airway pressure has been prescribed. 2. intended for single-patient re-use in the home, hospital, and sub-acute environment

Source page: https://510kreport.com/device/K131901
Methodology: https://510kreport.com/methodology