510(k) · Cleared
ClearedSunset Heated CPAP Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunset Healthcare Solutions, Inc. · BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Cleared on Jan 29, 2021 as substantially equivalent to K140424 (Respironics, Inc., 2014) after a 245-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Jan 29, 2021
- Review
- 245 days
- Class
- Class II
- Product code
- BZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K952292 (1995). 22 ancestors in all, the oldest K850647 (1985). No later device cites it as a predicate yet.
- Root · 8 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 7 generations backK961626 Solo Cpap SystemRespironics, Inc. · 1996
- 6 generations backK973161 Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd. · 1998
- 5 generations backK040941 Cpap Humidifier, Model HC234 (and Related Accessories)Fisher & Paykel Healthcare, Ltd. · 2004
- 4 generations backK041900 HC604 Cpap HumidifierFisher & Paykel Healthcare, Ltd. · 2004
- 3 generations backK100104 Hybernite Rainout Control SystemPlastiflex Group NV · 2010
- 2 generations backK110398 Respironics Disposable Heated Wire CircuitsRespironics, Inc. · 2011
- 1 generation backK140424 Respironics Reusable Heated TubingRespironics, Inc. · 2014
- This deviceK201418 Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K952292 | Puritan-Bennett Companion Nasal Cpap System | Puritan Bennett Corp. | 1995 | — |
| −7 | K961626 | Solo Cpap System | Respironics, Inc. | 1996 | — |
| −6 | K973161 | Cpap Humidifier (HC 200) | Fisher & Paykel Electronics, Ltd. | 1998 | — |
| −5 | K040941 | Cpap Humidifier, Model HC234 (and Related Accessories) | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −4 | K041900 | HC604 Cpap Humidifier | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −3 | K100104 | Hybernite Rainout Control System | Plastiflex Group NV | 2010 | — |
| −2 | K110398 | Respironics Disposable Heated Wire Circuits | Respironics, Inc. | 2011 | — |
| −1 | K140424 | Respironics Reusable Heated Tubing | Respironics, Inc. | 2014 | — |
| 0 (this device) | K201418 | Sunset Heated CPAP Tube | Sunset Healthcare Solutions, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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 BZE? 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 BZE device
- #1 K252066 inspired™ Heated Breathing Circuit (510-008)…score 13.3 · 7 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 |
|---|---|---|---|
| * | K140424 | Respironics Reusable Heated TubingSummary page 4…ing system, heater Classification 21 CFR 868.5270 Product Code: BZE Review Panel: Anesthesiology III. PREDICATE DEVICE K140424, Philips Respironics Reusable Heated Tubing, Respironics, Inc. IV. DEVICE DESCRIPTION… | 2014 |
| † | K113068 | Remstar Auto a-Flex HT | 2011 |
| † | K121623 | Bipap a 40 Ventilatory Support System | 2012 |
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 26 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 22 ancestors has a recall of any class.
- 1 other device also cites its predicate K140424.
How does its category compare?
All BZE devicesBZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · BZE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZE
241in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZE
No recall names BZE since 2007.
Adverse event reports per year · BZE
193in 2025
MAUDE reports naming product code BZE, 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 | 0 | — | 0 | 69 |
| 2008 | 0 | — | 0 | 74 |
| 2009 | 0 | — | 0 | 80 |
| 2010 | 2 | — | 0 | 126 |
| 2011 | 1 | — | 0 | 192 |
| 2012 | 2 | — | 0 | 334 |
| 2013 | 0 | — | 0 | 387 |
| 2014 | 1 | — | 0 | 338 |
| 2015 | 1 | — | 0 | 155 |
| 2016 | 5 | 241 | 0 | 214 |
| 2017 | 1 | — | 0 | 209 |
| 2018 | 1 | — | 0 | 103 |
| 2019 | 0 | — | 0 | 134 |
| 2020 | 0 | — | 0 | 123 |
| 2021 | 1 | — | 0 | 124 |
| 2022 | 0 | — | 0 | 152 |
| 2023 | 1 | — | 0 | 125 |
| 2024 | 2 | — | 0 | 172 |
| 2025 | 1 | — | 0 | 193 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Sunset Heated CPAP Tube is a heated wire breathing tube intended to provide warmed and/or humidified breathing gases before they enter a patient's airway. It is indicated for single-patient reuse in the home and in clinical settings, such as hospitals, institutions, sleep laboratories, and sub-acute care facilities. It may be used with non-invasive ventilation for adult patients. It is compatible with the Philips Respironics System One Heated Humidifier and Philips Respironics Dreamstation Heated Humidifier.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201418: Sunset Heated CPAP Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201418
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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