# K112271: 3B Willow

- Pathway: 510(k) (Traditional)
- Applicant: 3B Products, LLC
- Decided: Feb 16, 2012 after 192 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K952292 (1995). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042403: Mirage Swift, Resmed, Ltd. (2004) Summary page 1.
- K082558: Comfortlite Nasal Mask, Respironics, Inc. (2009) Summary page 1.
- K063036: Opus HC482 Direct Nasal Mask, Fisher & Paykel Healthcare, Ltd. (2006) Summary page 1.

## Most influential descendants
- K131901: Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N2 (2013), 0 descendants of its own

## Recalls of this device
- Jun 15, 2023 · Class II · Z-2740-2026: Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).

## Indications for use
The WillowTM channels airflow noninvasively to a patient from a positive airway pressure (PAP) device or a bilevel system The Willow TM is: (1) to be used by adult patients (>661b / 30 kg) for the treatment of sleep disordered breathing, such as obstructive sleep apnea (OSA), for whom positive airway pressure has been prescribed. (2) to be used for single-patient reuse in the home environment.

Source page: https://510kreport.com/device/K112271
Methodology: https://510kreport.com/methodology