510(k) · Cleared
ClearedDeltaWave Nasal Pillow System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
RemSleep Holdings, Inc. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Jan 7, 2026 as substantially equivalent to K233415 (Remsleep Holdings, 2024) after a 29-day review. Its family tree reaches back 12 generations to 1995.
- Decided
- Jan 7, 2026
- Review
- 29 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K952292 (1995). 32 ancestors in all, the oldest K900164 (1990). No later device cites it as a predicate yet.
- Root · 12 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 8 generations between
- 3 generations backK161412 F&P Brevida™ Nasal Pillows MaskFisher & Paykel Healthcare, Ltd. · 2017
- 2 generations backK200089 F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P…Fisher & Paykel Healthcare, Ltd. · 2020
- 1 generation backK233415 DELTAWAVE Nasal Pillows SystemRemsleep Holdings · 2024
- This deviceK253939 DeltaWave Nasal Pillow SystemRemSleep Holdings, Inc. · 2026
Show all 12 generations
- Root · 12 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 11 generations backK961626 Solo Cpap SystemRespironics, Inc. · 1996
- 10 generations backK973161 Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd. · 1998
- 9 generations backK040941 Cpap Humidifier, Model HC234 (and Related Accessories)Fisher & Paykel Healthcare, Ltd. · 2004
- 8 generations backK050904 Cpap Humidifier, Model HC238JHUFisher & Paykel Healthcare, Ltd. · 2005
- 7 generations backK063036 Opus HC482 Direct Nasal MaskFisher & Paykel Healthcare, Ltd. · 2006
- 6 generations backK080209 Fisher and Paykel Healthcare Zest Nasal MaskFisher & Paykel Healthcare, Ltd. · 2008
- 5 generations backK083832 Zest Nasal MaskFisher & Paykel Healthcare, Ltd. · 2009
- 4 generations backK120027 Pilairo Nasal Pillows MaskFisher & Paykel Healthcare Limited · 2012
- 3 generations backK161412 F&P Brevida™ Nasal Pillows MaskFisher & Paykel Healthcare, Ltd. · 2017
- 2 generations backK200089 F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P…Fisher & Paykel Healthcare, Ltd. · 2020
- 1 generation backK233415 DELTAWAVE Nasal Pillows SystemRemsleep Holdings · 2024
- This deviceK253939 DeltaWave Nasal Pillow SystemRemSleep Holdings, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K952292 | Puritan-Bennett Companion Nasal Cpap System | Puritan Bennett Corp. | 1995 | — |
| −11 | K961626 | Solo Cpap System | Respironics, Inc. | 1996 | — |
| −10 | K973161 | Cpap Humidifier (HC 200) | Fisher & Paykel Electronics, Ltd. | 1998 | — |
| −9 | K040941 | Cpap Humidifier, Model HC234 (and Related Accessories) | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −8 | K050904 | Cpap Humidifier, Model HC238JHU | Fisher & Paykel Healthcare, Ltd. | 2005 | — |
| −7 | K063036 | Opus HC482 Direct Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2006 | — |
| −6 | K080209 | Fisher and Paykel Healthcare Zest Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| −5 | K083832 | Zest Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2009 | — |
| −4 | K120027 | Pilairo Nasal Pillows Mask | Fisher & Paykel Healthcare Limited | 2012 | — |
| −3 | K161412 | F&P Brevida™ Nasal Pillows Mask | Fisher & Paykel Healthcare, Ltd. | 2017 | — |
| −2 | K200089 | F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora… | Fisher & Paykel Healthcare, Ltd. | 2020 | — |
| −1 | K233415 | DELTAWAVE Nasal Pillows System | Remsleep Holdings | 2024 | — |
| 0 (this device) | K253939 | DeltaWave Nasal Pillow System | RemSleep Holdings, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZD device
- #1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K233415 | DELTAWAVE Nasal Pillows SystemSummary page 5…Ventilator, Non-Continuous (Respirator) Product Code: BZD Regulation Number: 21 CFR 868.5905 Clearance Number: K233415 Reference Device Trade Name: Respironics, Inc. DreamWear Silicone Pillows Mask Common/Usual Name: Nasal Mask,… | 2024 |
| † | K210844 | DreamWear Silicone Pillows Mask | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 32 ancestors have a recall of any class.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 2025
MAUDE reports naming product code BZD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 21 | 83 | 29 | 65 |
| 2008 | 17 | 108 | 2 | 67 |
| 2009 | 23 | 90 | 1 | 147 |
| 2010 | 12 | 122 | 0 | 143 |
| 2011 | 23 | 125 | 1 | 189 |
| 2012 | 21 | 133 | 0 | 139 |
| 2013 | 23 | 127 | 0 | 82 |
| 2014 | 14 | 172 | 0 | 86 |
| 2015 | 11 | 224 | 0 | 114 |
| 2016 | 12 | 217 | 0 | 118 |
| 2017 | 5 | 221 | 0 | 148 |
| 2018 | 5 | 280 | 0 | 101 |
| 2019 | 6 | 231 | 4 (4) | 188 |
| 2020 | 6 | 137 | 0 | 126 |
| 2021 | 6 | 192 | 0 | 6,066 |
| 2022 | 4 | 253 | 0 | 90,768 |
| 2023 | 5 | 204 | 8 (7) | 27,987 |
| 2024 | 10 | 132 | 0 | 68,262 |
| 2025 | 7 | 189 | 0 | 60,279 |
| 2026 | 10 | 214 | 2 (2) | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253939 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253939: DeltaWave Nasal Pillow System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253939
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026