510(k) · Cleared
ClearedRT 138 & RT 141 Dual-Heated Neonatal Breathing Circuits
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 Jan 12, 2005 as substantially equivalent to K020332 (Fisher & Paykel Healthcare, Ltd., 2003) after a 380-day review. Its family tree reaches back 4 generations to 1992. 1 of the 21 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it.
- Decided
- Jan 12, 2005
- Review
- 380 days
- Class
- Class II
- Product code
- BZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K913368 (1992). 8 ancestors in all, the oldest K902506 (1991). 12 later devices descend from it, 2 citing it directly. 1 of the 21 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 3 generations backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- 2 generations backK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- 1 generation backK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- This deviceK034026 RT 138 & RT 141 Dual-Heated Neonatal Breathing CircuitsFisher & Paykel Healthcare, Ltd. · 2005
- Descendant · cites it directly · 10 of its ownK103767 Dual Heated Infant Vreathing CirouitsFisher & Paykel Healthcare, Ltd. · 2012
- Descendant · 2 generations on · 6 of its ownK122432 Adult Evaqua 2' Dual Heated Breathing CircuitsFisher & Paykel Healthcare, Ltd. · 2012
- Descendant · 2 generations on · 1 of its ownK220703 F&P 950 Respiratory HumidifierFisher & Paykel Healthcare · 2023
- Descendant · 2 generations on · 1 of its ownK222822 VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated…Draegerwerk AG & CO Kgaa · 2023
- Descendant · 2 generations on · 1 of its ownK152029 Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010…Hamilton Medical AG · 2016
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K173280 Neonatal ConchaSmart Breathing Circuits2 generations on · 2018
Most influential descendants
Showing 5 of 12 · See all- K103767Dual Heated Infant Vreathing CirouitsFisher & Paykel Healthcare, Ltd. · 2012 · cites it directly10descendants
- K122432Adult Evaqua 2' Dual Heated Breathing CircuitsFisher & Paykel Healthcare, Ltd. · 2012 · 2 generations on6descendants
- K220703F&P 950 Respiratory HumidifierFisher & Paykel Healthcare · 2023 · 2 generations on1descendant
- K222822VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)Draegerwerk AG & CO Kgaa · 2023 · 2 generations on1descendant
- K152029Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010, Hamilton-BC4010Hamilton Medical AG · 2016 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −3 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| −2 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| −1 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| 0 (this device) | K034026 | RT 138 & RT 141 Dual-Heated Neonatal Breathing Circuits | Fisher & Paykel Healthcare, Ltd. | 2005 | — |
| +1 | K103767 | Dual Heated Infant Vreathing Cirouits | Fisher & Paykel Healthcare, Ltd. | 2012 | — |
| +2 | K122432 | Adult Evaqua 2' Dual Heated Breathing Circuits | Fisher & Paykel Healthcare, Ltd. | 2012 | — |
| +2 | K220703 | F&P 950 Respiratory Humidifier | Fisher & Paykel Healthcare | 2023 | — |
| +2 | K222822 | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus… | Draegerwerk AG & CO Kgaa | 2023 | — |
| +2 | K152029 | Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010… | Hamilton Medical AG | 2016 | — |
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 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 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 |
|---|---|---|---|
| * | K020332 | Respiratory Humidifier, Model MR850Summary page 1…atal Breathing Circuit RT141 Dual Heated Neonatal Breathing Circuit Heated Breathing Circuit Breathing System Heater (21 CFR 868.5270) RT130 Neonatal Breathing Circuit K020332 RT131 Neonatal Breathing Circuit K020332 2y Fisher & Paykel Healthcare 510k Notification Dual-heated Neonatal Br… | 2003 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K103767 (Fisher & Paykel Healthcare, Ltd., 2012) has gone furthest, with 10 descendants of its own.
- 4 other devices also cite its predicate K020332.
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 | — |
What is it indicated for?
The dual-heated breathing circuits are intended as conduits of breathing gas for
ventilation of patients, and to maintain the temperature of humidified inspired gas.
The RT236 is used for flow rates between 0.3 and 4 L/min, and the RT235 is for flow
rates greater than 4 L/min, for infant patients.
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/K034026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K034026: RT 138 & RT 141 Dual-Heated Neonatal Breathing Circuits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K034026
Report an extraction error
Are you the manufacturer?
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