# K233415: DELTAWAVE Nasal Pillows System

- Pathway: 510(k) (Traditional)
- Applicant: Remsleep Holdings
- Decided: Jul 2, 2024 after 266 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: 11 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)
- K200089: F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model, Fisher & Paykel Healthcare, Ltd. (2020) Summary page 5.

## Most influential descendants
- K253939: DeltaWave Nasal Pillow System (2026), 0 descendants of its own

## Indications for use
The DELTAWAVE Nasal Pillows System is intended to noninvasively channel pressurized airflow to a patient from a Continuous Positive Airway Pressure (CPAP) or Bi-Level medical device. This medical device is intended for adult patients weighing 66 lbs (30kg), and for whom noninvasive Continuous Positive Airway Pressure (CPAP) or Bi-Level therapy has been prescribed by a physician or other authorized healthcare professional. It is intended for single-patient reuse in the home.

Source page: https://510kreport.com/device/K233415
Methodology: https://510kreport.com/methodology