510(k) · Cleared
ClearedVentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draegerwerk AG & CO Kgaa · BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Cleared on Jun 14, 2023 as substantially equivalent to K103767 (Fisher & Paykel Healthcare, Ltd., 2012) and 1 other predicate after a 268-day review. Its family tree reaches back 7 generations to 1992. 1 later device descends from it.
- Decided
- Jun 14, 2023
- Review
- 268 days
- Class
- Class II
- Product code
- BZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K913368 (1992). 13 ancestors in all, the oldest K902506 (1991). 1 later device descends from it, 1 citing it directly.
- 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 backK033710 MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd. · 2004
- 2 generations backK073706 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2008
- 1 generation backK102618 Ventstar Heated, Infinity ID Breathing Circuit HeatedDraeger Medical AG & Co. KG · 2010
- This deviceK222822 VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated…Draegerwerk AG & CO Kgaa · 2023
- Descendant · cites it directly · 0 of its ownK242769 VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N)…Draegerwerk AG & CO Kgaa · 2025
Most influential descendants
Showing 1 of 1 · See all- K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)Draegerwerk AG & CO Kgaa · 2025 · cites it directly0descendants
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 | K033710 | MR850 Respiratory Humidifier, Model MR850JHU | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −2 | K073706 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| −1 | K102618 | Ventstar Heated, Infinity ID Breathing Circuit Heated | Draeger Medical AG & Co. KG | 2010 | — |
| 0 (this device) | K222822 | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus… | Draegerwerk AG & CO Kgaa | 2023 | — |
| +1 | K242769 | VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) | Draegerwerk AG & CO Kgaa | 2025 | — |
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 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (2)
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 4…ted N Exten. Kit: RT265 Dual Heated Infant Breathing Circuit, Fisher & Paykel HealthCare, cleared via K103767; Secondary predicate for VentStar Helix Heated (N) Plus: MP00… | 2012 |
| * | K102618 | Ventstar Heated, Infinity ID Breathing Circuit HeatedSummary page 4…or VentStar Helix Heated (N) Plus: MP00308 VentStar heated (N), Drägerwerk AG & Co. KGaA, cleared via K102618 Page 1/12 VentStar Helix Dua… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242769 | VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) | 2025 | 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 31 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K242769 (Draegerwerk AG & CO Kgaa, 2025) has gone furthest, with 0 descendants 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. 2023, 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?
VentStar Helix dual heated N Exten. Kit (MP02280): Inspiratory and expiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.
VentStar Helix heated (N) Plus (MP02608): Inspiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222822 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222822: VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222822
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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