510(k) · Cleared
ClearedIntersurgical Heated Wire Breathing Systems and Humidification Chambers, Model 2026,2026-CH, 2310, 2320, 2330
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intersurgical, Inc. · BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Cleared on May 18, 2010 as substantially equivalent to K850647 (Fisher & Paykel Allied Products, Ltd., 1985) and 1 other predicate after a 307-day review. Its family tree reaches back 1 generation to 1985. 7 later devices descend from it.
- Decided
- May 18, 2010
- Review
- 307 days
- Class
- Class II
- Product code
- BZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K850647 (1985). 2 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK850647 Heated Respiratory Humififier MR440Fisher & Paykel Allied Products, Ltd. · 1985
- This deviceK092129 Intersurgical Heated Wire Breathing Systems and Humidification…Intersurgical, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK110398 Respironics Disposable Heated Wire CircuitsRespironics, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK151461 Hybernite RTPlastiflex Group NV · 2016
- Descendant · 2 generations on · 2 of its ownK140424 Respironics Reusable Heated TubingRespironics, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK253322 Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 /…Medline Industries, LP · 2026
- Descendant · 3 generations on · 0 of its ownK241268 Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron Medical · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K110398Respironics Disposable Heated Wire CircuitsRespironics, Inc. · 2011 · cites it directly3descendants
- K151461Hybernite RTPlastiflex Group NV · 2016 · cites it directly2descendants
- K140424Respironics Reusable Heated TubingRespironics, Inc. · 2014 · 2 generations on2descendants
- K253322Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant…Medline Industries, LP · 2026 · 2 generations on0descendants
- K241268Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron Medical · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K850647 | Heated Respiratory Humififier MR440 | Fisher & Paykel Allied Products, Ltd. | 1985 | — |
| 0 (this device) | K092129 | Intersurgical Heated Wire Breathing Systems and Humidification Chambers, Model… | Intersurgical, Inc. | 2010 | — |
| +1 | K110398 | Respironics Disposable Heated Wire Circuits | Respironics, Inc. | 2011 | — |
| +1 | K151461 | Hybernite RT | Plastiflex Group NV | 2016 | — |
| +2 | K140424 | Respironics Reusable Heated Tubing | Respironics, Inc. | 2014 | — |
| +2 | K253322 | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78”… | Medline Industries, LP | 2026 | — |
| +3 | K241268 | Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) | Exceleron Medical | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K850647 | Heated Respiratory Humififier MR440Summary page 5…2320 F & P MR 210 510K _______________ K850647 intended use: Humidification Chambens are Humidification Chambers… | 1985 |
| * | K862923 | MR620 Dual Servo Heated Anaesthesia HumidifierSummary page 7…2330 F &P MR225 510K 1862923 K______________ Intend… | 1986 |
| * | — | Fisher & Paykel RT2100 dual wire heated breathing circuit Named without a submission number | |
| * | — | Fisher & Paykel MR 290 Autofeed Humidification Chamber Named without a submission number |
What descends from it? (7)
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?
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?
Breathing system heaters are defined as a device that is intended to
warm breathing gases before they enter a patient's airway.
Humidification chambers are intended for use to hold water required
to humidify the air being delivered to patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092129 · printed Nov 3, 2026
Cite this page
510(k) Report. “K092129: Intersurgical Heated Wire Breathing Systems and Humidification Chambers, Model 2026,2026-CH, 2310, 2320, 2330.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K092129
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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