510(k) · Cleared
ClearedHybernite Rainout Control System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plastiflex Group NV · BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Cleared on Apr 14, 2010 as substantially equivalent to K071958 (Smiths Medical Asd, Inc., 2007) and 1 other predicate after a 91-day review. Its family tree reaches back 5 generations to 1995. 6 later devices descend from it.
- Decided
- Apr 14, 2010
- Review
- 91 days
- Class
- Class II
- Product code
- BZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K952292 (1995). 11 ancestors in all, the oldest K913368 (1992). 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 4 generations backK961626 Solo Cpap SystemRespironics, Inc. · 1996
- 3 generations backK973161 Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd. · 1998
- 2 generations backK040941 Cpap Humidifier, Model HC234 (and Related Accessories)Fisher & Paykel Healthcare, Ltd. · 2004
- 1 generation backK041900 HC604 Cpap HumidifierFisher & Paykel Healthcare, Ltd. · 2004
- This deviceK100104 Hybernite Rainout Control SystemPlastiflex Group NV · 2010
- Descendant · cites it directly · 3 of its ownK110398 Respironics Disposable Heated Wire CircuitsRespironics, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK140424 Respironics Reusable Heated TubingRespironics, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK122705 Humicare D900Grundler GmbH · 2013
- Descendant · 3 generations on · 0 of its ownK241268 Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron Medical · 2024
- Descendant · 3 generations on · 0 of its ownK201418 Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K110398Respironics Disposable Heated Wire CircuitsRespironics, Inc. · 2011 · cites it directly3descendants
- K140424Respironics Reusable Heated TubingRespironics, Inc. · 2014 · 2 generations on2descendants
- K122705Humicare D900Grundler GmbH · 2013 · cites it directly1descendant
- K241268Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron Medical · 2024 · 3 generations on0descendants
- K201418Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K952292 | Puritan-Bennett Companion Nasal Cpap System | Puritan Bennett Corp. | 1995 | — |
| −4 | K961626 | Solo Cpap System | Respironics, Inc. | 1996 | — |
| −3 | K973161 | Cpap Humidifier (HC 200) | Fisher & Paykel Electronics, Ltd. | 1998 | — |
| −2 | K040941 | Cpap Humidifier, Model HC234 (and Related Accessories) | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −1 | K041900 | HC604 Cpap Humidifier | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| 0 (this device) | K100104 | Hybernite Rainout Control System | Plastiflex Group NV | 2010 | — |
| +1 | K110398 | Respironics Disposable Heated Wire Circuits | Respironics, Inc. | 2011 | — |
| +2 | K140424 | Respironics Reusable Heated Tubing | Respironics, Inc. | 2014 | — |
| +1 | K122705 | Humicare D900 | Grundler GmbH | 2013 | — |
| +3 | K241268 | Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) | Exceleron Medical | 2024 | — |
| +3 | K201418 | Sunset Heated CPAP Tube | Sunset Healthcare Solutions, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K071958 | Thera-Heat Heated Humidifier and Adult Dual and Single Limb Heated Wire Ventilator…Summary page 1…Breathing Tube Classification Name, Breathing system heater, Number & 868.5270, Product Code: BZE Preicae Dvics: K071958 THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS… | 2007 |
| * | K041900 | HC604 Cpap HumidifierSummary page 1…ics: K071958 THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS K041900 F&P HC 600 CPAP HUMIDIFIER including the Thermnosmart® heated tubing Devie Decritionand… | 2004 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K110398 (Respironics, Inc., 2011) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K071958.
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. 2010, 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 Hybernite Rainout Control System is a heated breathing circuit intended to provide warmed and/or humidified breathing gases before entering the patient airway. The Hybernite device is intended for incorporation into OPAP (continuous positive airway pressure) devices and is intended to act as a conduit for the breathing gasses delivered from the humidifier to the patient. After the gas is warmed and humidified in the humidifier, it is delivered…
Read the full statement (162 words)
The Hybernite Rainout Control System is a heated breathing circuit intended to provide warmed and/or humidified breathing gases before entering the patient airway. The Hybernite device is intended for incorporation into OPAP (continuous positive airway pressure) devices and is intended to act as a conduit for the breathing gasses delivered from the humidifier to the patient. After the gas is warmed and humidified in the humidifier, it is delivered through the heated tubing to the patient. The purpose of the Hybenite Rainout Control System is to maintain or raise the gas temperature to or above the dew point (of the air exiting the humidifier) reducing or eliminating water condensation and/or pooling of water in the breathing circuit, and problems associated with such. The Hybernite Rainout Control System is indicated for use in the home or sleep-lab setting by a single adult patient. It can also be used in conjunction with supplemental Oxygen. The Hybernite Rainout Control System is indicated for non-invasive ventilation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100104 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100104: Hybernite Rainout Control System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100104
Report an extraction error
Are you the manufacturer?
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