510(k) · Cleared
ClearedHeated Breathing Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Eda Technology Co., Ltd. · BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Cleared on Jul 25, 2025 as substantially equivalent to K110860 (Omron Healthcare, Inc., 2011) after a 287-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Jul 25, 2025
- Review
- 287 days
- Class
- Class II
- Product code
- BZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K914836 (1992). No later device cites it as a predicate yet.
- Root · 3 generations backK914836 Omron Compressor Nebulizer- Model NE-C09Omron Healthcare, Inc. · 1992
- 2 generations backK060811 Omron Compressor Systems, Models NE-C28,NE-C30Omron Healthcare, Inc. · 2006
- 1 generation backK110860 Comp a-I-ROmron Healthcare, Inc. · 2011
- This deviceK243244 Heated Breathing TubeGuangdong Eda Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914836 | Omron Compressor Nebulizer- Model NE-C09 | Omron Healthcare, Inc. | 1992 | — |
| −2 | K060811 | Omron Compressor Systems, Models NE-C28,NE-C30 | Omron Healthcare, Inc. | 2006 | — |
| −1 | K110860 | Comp a-I-R | Omron Healthcare, Inc. | 2011 | — |
| 0 (this device) | K243244 | Heated Breathing Tube | Guangdong Eda Technology Co., Ltd. | 2025 | — |
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 |
|---|---|---|---|
| * | K110860 | Comp a-I-RSummary page 5…lizer Regulatory Class Class II Classification 21CFR §868.5630 / Nebulizer Submission type Traditional 510(K) 4. Predicate Device Information K110860, NE-C801 Nebulizer Compressor System, Omron Healthcare, Incorporated 5. Device Description The compressor Nebulizer is mainly co… | 2011 |
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 33 years and passes through 2 companies; a new generation was cleared every 13.9 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K110860.
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. 2025, 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 Heated Breathing Tube is intended to be used for non-invasive respiratory therapy, such as CPAP/BiPAP therapy. It provides air connection between positive pressure ventilation, respiratory humidification therapy instrument, and ventilation mask, nasal cannula, trachea cannula etc. With the function of heating inside breathing tube, it can prevent condensation of the therapy air in the tube.
This device is single patient use only for adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243244: Heated Breathing Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243244
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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