510(k) · Cleared
ClearedDual Heated Infant Vreathing Cirouits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Healthcare, Ltd. · BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Cleared on Apr 16, 2012 as substantially equivalent to K034026 (Fisher & Paykel Healthcare, Ltd., 2005) after a 480-day review. Its family tree reaches back 5 generations to 1992. 1 of the 20 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.
- Decided
- Apr 16, 2012
- Review
- 480 days
- Class
- Class II
- Product code
- BZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K913368 (1992). 9 ancestors in all, the oldest K902506 (1991). 10 later devices descend from it, 6 citing it directly. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 4 generations backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- 3 generations backK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- 2 generations backK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- 1 generation backK034026 RT 138 & RT 141 Dual-Heated Neonatal Breathing CircuitsFisher & Paykel Healthcare, Ltd. · 2005
- This deviceK103767 Dual Heated Infant Vreathing CirouitsFisher & Paykel Healthcare, Ltd. · 2012
- Descendant · cites it directly · 6 of its ownK122432 Adult Evaqua 2' Dual Heated Breathing CircuitsFisher & Paykel Healthcare, Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK220703 F&P 950 Respiratory HumidifierFisher & Paykel Healthcare · 2023
- Descendant · cites it directly · 1 of its ownK222822 VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated…Draegerwerk AG & CO Kgaa · 2023
- Descendant · cites it directly · 1 of its ownK152029 Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010…Hamilton Medical AG · 2016
- Descendant · cites it directly · 0 of its ownK252066 inspired™ Heated Breathing Circuit (510-008); inspired™ Heated…Vincent Healthcare Products Limited · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K173280 Neonatal ConchaSmart Breathing Circuitscites it directly · 2018
Most influential descendants
Showing 5 of 10 · See all- K122432Adult Evaqua 2' Dual Heated Breathing CircuitsFisher & Paykel Healthcare, Ltd. · 2012 · cites it directly6descendants
- K220703F&P 950 Respiratory HumidifierFisher & Paykel Healthcare · 2023 · cites it directly1descendant
- K222822VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)Draegerwerk AG & CO Kgaa · 2023 · cites it directly1descendant
- K152029Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010, Hamilton-BC4010Hamilton Medical AG · 2016 · cites it directly1descendant
- K252066inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit…Vincent Healthcare Products Limited · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −4 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| −3 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| −2 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| −1 | K034026 | RT 138 & RT 141 Dual-Heated Neonatal Breathing Circuits | Fisher & Paykel Healthcare, Ltd. | 2005 | — |
| 0 (this device) | K103767 | Dual Heated Infant Vreathing Cirouits | Fisher & Paykel Healthcare, Ltd. | 2012 | — |
| +1 | K122432 | Adult Evaqua 2' Dual Heated Breathing Circuits | Fisher & Paykel Healthcare, Ltd. | 2012 | — |
| +1 | K220703 | F&P 950 Respiratory Humidifier | Fisher & Paykel Healthcare | 2023 | — |
| +1 | K222822 | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus… | Draegerwerk AG & CO Kgaa | 2023 | — |
| +1 | K152029 | Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010… | Hamilton Medical AG | 2016 | — |
| +1 | K252066 | inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing… | Vincent Healthcare Products Limited | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 1 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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.
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? (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 |
|---|---|---|---|
| * | K034026 | RT 138 & RT 141 Dual-Heated Neonatal Breathing CircuitsSummary page 1…ircuit Classification name Breathing System Heater Class 11 (21 CFR § 868.5270), product code BZE Predicate device K034026 Fisher & Paykel Healthcare RT235 and RT236 Dual Heated Neonatal Breathing Circuits 2 1 Referred t… | 2005 |
What descends from it? (10)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122432 | Adult Evaqua 2' Dual Heated Breathing Circuits | 2012 | 6 |
| K220703 | F&P 950 Respiratory Humidifier | 2023 | 1 |
| K222822 | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) | 2023 | 1 |
| K152029 | Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010, Hamilton-BC4010 | 2016 | 1 |
| K252066 | inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit… | 2026 | 0 |
| K173280 | Neonatal ConchaSmart Breathing Circuits Class I | 2018 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K173280Neonatal ConchaSmart Breathing CircuitsTeleflexmedical, Inc. · 2018 · Cites it directly · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K122432 (Fisher & Paykel Healthcare, Ltd., 2012) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K034026.
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. 2012, 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 dual-heated breathing circuits are intended as conduits of breathing gas for ventilation of infant patients, and to maintain the temperature of humidified inspired gas. The RT265 is used for flow rates greater than 4 L/min, and the RT266 is for flow rates between 0.3 and 4 L/min.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103767 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103767: Dual Heated Infant Vreathing Cirouits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103767
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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