# K253939: DeltaWave Nasal Pillow System

- Pathway: 510(k) (Special)
- Applicant: RemSleep Holdings, Inc.
- Decided: Jan 7, 2026 after 29 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: 12 generations back to K952292 (1995). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233415: DELTAWAVE Nasal Pillows System, Remsleep Holdings (2024) Summary page 5.

## Indications for use
The DeltaWave Nasal Pillow System channels airflow noninvasively to a patient from a noninvasive positive airway pressure device (PAP) such as CPAP, bi-level. It is intended for adult patients weighing ≥66lbs (30 Kg), and for whom positive airway pressure has been prescribed. It is intended for single patient reuse in the home and hospital/institutional/sleep center environment.

Source page: https://510kreport.com/device/K253939
Methodology: https://510kreport.com/methodology