510(k) · Cleared
ClearedAirLife Infant Single Limb Heated Wire Circuit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carefusion, Inc. · BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Cleared on Jan 20, 2016 as substantially equivalent to K000697 (Allegiance Healthcare Corp., 2000) after a 188-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Jan 20, 2016
- Review
- 188 days
- Class
- Class II
- Product code
- BZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000697 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000697 Modification to Airlife Heated Ventilator and Anesthesia Breathing…Allegiance Healthcare Corp. · 2000
- This deviceK151959 AirLife Infant Single Limb Heated Wire CircuitCarefusion, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000697 | Modification to Airlife Heated Ventilator and Anesthesia Breathing Circuits | Allegiance Healthcare Corp. | 2000 | — |
| 0 (this device) | K151959 | AirLife Infant Single Limb Heated Wire Circuit | Carefusion, Inc. | 2016 | — |
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 |
|---|---|---|---|
| * | K000697 | Modification to Airlife Heated Ventilator and Anesthesia Breathing CircuitsSummary page 4…BZE 3. Predicate Device This submission demonstrates substantial equivalence to the AirLife Heated Ventilator and Anesthesia Breathing Circuits, K000697 was cleared on March 30, 2000. This predicate device has not been subject to a design-related recall. 4. Device Description… | 2000 |
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?
- Its one ancestor has no recall.
- 6 other devices also cite its predicate K000697.
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. 2016, 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 circuit is intended to deliver and warm breathing gases before they enter the patient’s airway. The heated breathing circuit is used with Fisher and Paykel heated humidifier MR850. The AirLife Infant Single Limb Heated Wire Circuit is intended for use with pediatric population, specifically the neonate (birth to 1 month of age) and infant (greater than 1 month to 2 years of age) pediatric subgroups. The product is single use device, non-sterile and used in professional healthcare environments and intra-hospital transport environments under a doctor’s supervision and by skilled clinicians.
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/K151959 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151959: AirLife Infant Single Limb Heated Wire Circuit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151959
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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