510(k) · Cleared
ClearedHybernite RT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plastiflex Group NV · BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Cleared on Mar 24, 2016 as substantially equivalent to K092129 (Intersurgical, Inc., 2010) after a 297-day review. Its family tree reaches back 2 generations to 1985. 2 later devices descend from it.
- Decided
- Mar 24, 2016
- Review
- 297 days
- Class
- Class II
- Product code
- BZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K850647 (1985). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK850647 Heated Respiratory Humififier MR440Fisher & Paykel Allied Products, Ltd. · 1985
- 1 generation backK092129 Intersurgical Heated Wire Breathing Systems and Humidification…Intersurgical, Inc. · 2010
- This deviceK151461 Hybernite RTPlastiflex Group NV · 2016
- Descendant · cites it directly · 0 of its ownK253322 Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 /…Medline Industries, LP · 2026
- Descendant · cites it directly · 0 of its ownK234032 Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult…Medline Industries, LP · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850647 | Heated Respiratory Humififier MR440 | Fisher & Paykel Allied Products, Ltd. | 1985 | — |
| −1 | K092129 | Intersurgical Heated Wire Breathing Systems and Humidification Chambers, Model… | Intersurgical, Inc. | 2010 | — |
| 0 (this device) | K151461 | Hybernite RT | Plastiflex Group NV | 2016 | — |
| +1 | K253322 | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78”… | Medline Industries, LP | 2026 | — |
| +1 | K234032 | Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit… | Medline Industries, LP | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K092129 | Intersurgical Heated Wire Breathing Systems and Humidification Chambers, Model…Summary page 4…Heated Breathing Tube Classification Name, Breathing system heater, Number & 868.5270, Product Code: BZE Predicate Device: K092129 INTERSURGICAL HEATED WIRE BREATHING SYSTEM Reference Device: K100104 PLASTIFLEX HEALTHCARE HYBERNITE RAINOUT… | 2010 |
| † | K100104 | Hybernite Rainout Control System | 2010 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 31 years and passes through 3 companies; a new generation was cleared every 25.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K253322 (Medline Industries, LP, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K092129.
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 Hybernite RT heated breathing circuits are intended to carry warmed/moistened gas from the humidifier to the patient’s airways. The Hybernite RT breathing tubes are indicated for patient populations from neonates to adults. They may be used in the home or hospital environments.
They are for single patient use only.
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/K151461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151461: Hybernite RT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151461
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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