510(k) · Cleared
Clearedinspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™ Auto-feed Humidification Chamber (VHC10); inspired™ Auto-feed Humidification Chamber (VHC20)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vincent Healthcare Products Limited · BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Cleared on Jun 18, 2026 as substantially equivalent to K122432 (Fisher & Paykel Healthcare, Ltd., 2012) and 2 other predicates after a 352-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- Jun 18, 2026
- Review
- 352 days
- Class
- Class II
- Product code
- BZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K913368 (1992). 11 ancestors in all, the oldest K902506 (1991). No later device cites it as a predicate yet.
- Root · 7 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 6 generations backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- 5 generations backK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- 4 generations backK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- 3 generations backK034026 RT 138 & RT 141 Dual-Heated Neonatal Breathing CircuitsFisher & Paykel Healthcare, Ltd. · 2005
- 2 generations backK103767 Dual Heated Infant Vreathing CirouitsFisher & Paykel Healthcare, Ltd. · 2012
- 1 generation backK122432 Adult Evaqua 2' Dual Heated Breathing CircuitsFisher & Paykel Healthcare, Ltd. · 2012
- This deviceK252066 inspired™ Heated Breathing Circuit (510-008); inspired™ Heated…Vincent Healthcare Products Limited · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −6 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| −5 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| −4 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| −3 | K034026 | RT 138 & RT 141 Dual-Heated Neonatal Breathing Circuits | Fisher & Paykel Healthcare, Ltd. | 2005 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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 K253322 Hudson RCI® Infant Dri-TechTM Breathing…score 11.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K122432 | Adult Evaqua 2' Dual Heated Breathing CircuitsSummary page 5…ation Name: Breathing system heater 21 CFR 868.5270 Product Code: BZE Predicate 1 Device: K122432 – Fisher & Paykel RT380 and RT 385 Adult Evaqua 2 Dual Heated Breathing Circuit Subject Device 2 Proprietary or Trade Name:… | 2012 |
| * | K103767 | Dual Heated Infant Vreathing CirouitsSummary page 5…ation Name: Breathing system heater 21 CFR 868.5270 Product Code: BZE Predicate 2 Device: K103767 – Fisher & Paykel RT265 Dual Heated Infant Breathing Circuit Subject Device 3 Proprietary or Trade Name: inspired™ VH… | 2012 |
| * | K934140 | MR290 Humidification Chamber Single UseSummary page 6…Respiratory gas humidifier 21 CFR 868.5450 Product Code: BTT Predicate 3 Device K934140 – MR290 Humidification Chamber Single Use Device Description The inspired™ Heated Breathing Circuit acts as a heated conduit to… | 1994 |
| † | K222351 | inspired™ VHB20 Heated Humidifier | 2022 |
| † | K160764 | AirLife Autofill Humidification Chamber | 2016 |
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?
- The line of descent spans 34 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 11 ancestors have a recall of any class.
- 3 other devices also cite its predicate K122432.
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. 2026, 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 inspired™ Heated Breathing Circuit acts as a heated conduit to deliver warmed and humidified medical gases to adult and infant patients experiencing respiratory conditions requiring mechanical ventilation, positive pressure breathing assistance or other respiratory support. This is a non-sterile single use product. To be used by trained clinical personnel in a hospital environment only. Compatible with the inspired™ VHB20 Heated Humidifier. This…
Read the full statement (133 words)
The inspired™ Heated Breathing Circuit acts as a heated conduit to deliver warmed and humidified medical gases to adult and infant patients experiencing respiratory conditions requiring mechanical ventilation, positive pressure breathing assistance or other respiratory support. This is a non-sterile single use product. To be used by trained clinical personnel in a hospital environment only. Compatible with the inspired™ VHB20 Heated Humidifier.
This inspired™ Auto-feed Humidification Chamber acts as a reservoir for water for inhalation. In conjunction with a humidifier, this water is heated to warm and humidify medical gases delivered to patients experiencing respiratory conditions requiring mechanical ventilation, positive pressure breathing assistance or other respiratory support. This is a non-sterile single use product. To be used by trained clinical personnel in a hospital environment only. Compatible with the inspired™ VHB20 Heated Humidifier.
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/K252066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252066: inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™ Auto-feed Humidification Chamber (VHC10); inspired™ Auto-feed Humidification Chamber (VHC20).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252066
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026