510(k) · Cleared
Recalled · Class I · 2014Isothermal Heated Ventilator & Anesthesia Circuit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Cleared on Jan 12, 1993 after a 419-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has a Class I recall. It has been recalled 4 times, including 3 Class I recalls.
- Decided
- Jan 12, 1993
- Review
- 419 days
- Class
- Class II
- Product code
- BZE
- Recalls
- 4 (3 Class I)
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 31, 2014 | Class II | Z-2689-2014 | No Marketing Application | The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas pathway may potentially impact the safety of the device and quality of the… |
| May 29, 2012 | Class I | Z-1900-2012 | Equipment maintenance | The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient. |
| May 29, 2012 | Class I | Z-1901-2012 | Equipment maintenance | The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient. |
| May 29, 2012 | Class I | Z-1899-2012 | Equipment maintenance | The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient. |
No ancestor or descendant has a Class I recall.
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.
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 | — |
https://510kreport.com/device/K915226 · printed Nov 4, 2026
Cite this page
510(k) Report. “K915226: Isothermal Heated Ventilator & Anesthesia Circuit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K915226
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026