# K210844: DreamWear Silicone Pillows Mask

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Aug 24, 2021 after 155 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: 8 generations back to K945938 (1996). 33 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140980: TI Nasal Mask, Respironics, Inc. (2015) Summary page 4.

## Most influential descendants
- K253166: F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) (2026), 0 descendants of its own

## Indications for use
The DreamWear Silicone Pillows Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.

Source page: https://510kreport.com/device/K210844
Methodology: https://510kreport.com/methodology