510(k) · Cleared
ClearedAdult Evaqua 2' Dual Heated 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 Dec 6, 2012 as substantially equivalent to K103767 (Fisher & Paykel Healthcare, Ltd., 2012) after a 118-day review. Its family tree reaches back 6 generations to 1992. 6 later devices descend from it.
- Decided
- Dec 6, 2012
- Review
- 118 days
- Class
- Class II
- Product code
- BZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913368 (1992). 10 ancestors in all, the oldest K902506 (1991). 6 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 5 generations backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- 4 generations backK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- 3 generations backK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- 2 generations backK034026 RT 138 & RT 141 Dual-Heated Neonatal Breathing CircuitsFisher & Paykel Healthcare, Ltd. · 2005
- 1 generation backK103767 Dual Heated Infant Vreathing CirouitsFisher & Paykel Healthcare, Ltd. · 2012
- This deviceK122432 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 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
- Descendant · 2 generations on · 0 of its ownK233821 F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK163283 Hamilton-H900, Hamilton-BC8010, Hamilton-BC4010Hamilton Medical AG · 2017 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K220703F&P 950 Respiratory HumidifierFisher & Paykel Healthcare · 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
- K233821F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd. · 2024 · 2 generations on0descendants
- K163283Hamilton-H900, Hamilton-BC8010, Hamilton-BC4010Hamilton Medical AG · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −5 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| −4 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| −3 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| −2 | 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 | — |
| 0 (this device) | 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 | 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 | — |
| +2 | K233821 | F&P Optiflow Oxygen Kit (AA451J) | Fisher & Paykel Healthcare, Ltd. | 2024 | — |
| +2 | K163283 | Hamilton-H900, Hamilton-BC8010, Hamilton-BC4010 | Hamilton Medical AG | 2017 | 1 |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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.
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 |
|---|---|---|---|
| * | K103767 | Dual Heated Infant Vreathing CirouitsSummary page 1…ircuit Classification name Breathing System Heater Class 11 (21 CFR § 868.5270), product code BZE Predicate device K103767 Fisher & Paykel Healthcare 2… | 2012 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220703 | F&P 950 Respiratory Humidifier | 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 |
| K150900 | Flexicare Heated Wire Breathing Systems | 2015 | 0 |
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 20 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K220703 (Fisher & Paykel Healthcare, 2023) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K103767.
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 RT380 and RT385 'Adult Evaqua 2' dual-heated breathing circuits are intended as conduits of breathing gas for ventilation of adult patients, and to maintain the temperature of humidified, inspired gas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122432 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122432: Adult Evaqua 2' Dual Heated 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/K122432
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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