510(k) · Cleared
ClearedRespironics Disposable Heated Wire Circuits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Cleared on Jun 1, 2011 as substantially equivalent to K100104 (Plastiflex Group NV, 2010) and 2 other predicates after a 110-day review. Its family tree reaches back 6 generations to 1995. 3 later devices descend from it.
- Decided
- Jun 1, 2011
- Review
- 110 days
- Class
- Class II
- Product code
- BZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K952292 (1995). 20 ancestors in all, the oldest K850647 (1985). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 5 generations backK961626 Solo Cpap SystemRespironics, Inc. · 1996
- 4 generations backK973161 Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd. · 1998
- 3 generations backK040941 Cpap Humidifier, Model HC234 (and Related Accessories)Fisher & Paykel Healthcare, Ltd. · 2004
- 2 generations backK041900 HC604 Cpap HumidifierFisher & Paykel Healthcare, Ltd. · 2004
- 1 generation backK100104 Hybernite Rainout Control SystemPlastiflex Group NV · 2010
- This deviceK110398 Respironics Disposable Heated Wire CircuitsRespironics, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK140424 Respironics Reusable Heated TubingRespironics, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK241268 Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron Medical · 2024
- Descendant · 2 generations on · 0 of its ownK201418 Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See all- K140424Respironics Reusable Heated TubingRespironics, Inc. · 2014 · cites it directly2descendants
- K241268Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron Medical · 2024 · 2 generations on0descendants
- K201418Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K952292 | Puritan-Bennett Companion Nasal Cpap System | Puritan Bennett Corp. | 1995 | — |
| −5 | K961626 | Solo Cpap System | Respironics, Inc. | 1996 | — |
| −4 | K973161 | Cpap Humidifier (HC 200) | Fisher & Paykel Electronics, Ltd. | 1998 | — |
| −3 | K040941 | Cpap Humidifier, Model HC234 (and Related Accessories) | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −2 | K041900 | HC604 Cpap Humidifier | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −1 | K100104 | Hybernite Rainout Control System | Plastiflex Group NV | 2010 | — |
| 0 (this device) | K110398 | Respironics Disposable Heated Wire Circuits | Respironics, Inc. | 2011 | — |
| +1 | K140424 | Respironics Reusable Heated Tubing | Respironics, Inc. | 2014 | — |
| +2 | K241268 | Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) | Exceleron Medical | 2024 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K100104 | Hybernite Rainout Control SystemSummary page 2…(performance standards). Predicate Device Namne(s) and 1. Plastiflex Healthcare 1lybernite Rainout Control 510(k) numbers: System - K100104 date of concurrence 04/14/2010) 2. 1Intesurgical Heated Wire Breathing System -… | 2010 |
| * | K092129 | Intersurgical Heated Wire Breathing Systems and Humidification Chambers, Model…Summary page 2…K100104 date of concurrence 04/14/2010) 2. 1Intesurgical Heated Wire Breathing System - K092 129 (date of concurrence 05/18/20 10) 3Fisher & Paykel Respiratory Humidifier - K9831 12… | 2010 |
| * | K983112 | Respiratory Humidifier, Model # MR850Summary page 2…- K092 129 (date of concurrence 05/18/20 10) 3Fisher & Paykel Respiratory Humidifier - K9831 12 (date of concurrence 11/10/1996) Reason for submission: New Device De… | 1998 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140424 | Respironics Reusable Heated Tubing | 2014 | 2 |
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 16 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K140424 (Respironics, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K100104.
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. 2011, 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 disposable heated wire circuit is a heated wire breathing circuit intended to provide warmed and/or humidified breathing gases before they enter a patient's airway. The disposable heated wire circuit is indicated for use by a single adult or pediatric patient in the home, hospital and/or institutional settings. It may be used for both invasive and non-invasive ventilation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110398: Respironics Disposable Heated Wire Circuits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110398
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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