510(k) · Cleared
ClearedVentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draegerwerk AG & CO Kgaa · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on Apr 4, 2025 as substantially equivalent to K892885 (Fisher & Paykel Electronics, Ltd., 1989) and 1 other predicate after a 203-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Apr 4, 2025
- Review
- 203 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K913368 (1992). 15 ancestors in all, the oldest K892885 (1989). No later device cites it as a predicate yet.
- Root · 8 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 7 generations backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- 6 generations backK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- 5 generations backK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- 4 generations backK033710 MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd. · 2004
- 3 generations backK073706 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2008
- 2 generations backK102618 Ventstar Heated, Infinity ID Breathing Circuit HeatedDraeger Medical AG & Co. KG · 2010
- 1 generation backK222822 VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated…Draegerwerk AG & CO Kgaa · 2023
- This deviceK242769 VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N)…Draegerwerk AG & CO Kgaa · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −7 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| −6 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| −5 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| −4 | K033710 | MR850 Respiratory Humidifier, Model MR850JHU | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −3 | K073706 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| −2 | K102618 | Ventstar Heated, Infinity ID Breathing Circuit Heated | Draeger Medical AG & Co. KG | 2010 | — |
| −1 | K222822 | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus… | Draegerwerk AG & CO Kgaa | 2023 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 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 BTL? 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 BTL device
- #1 K221634 Oxymag - Transport and Emergency Ventilatorscore 7.2 · 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 |
|---|---|---|---|
| * | K892885 | Resubmitted RD1000 Neopuff Infant ResuscitatorSummary page 5…II Predicate Device: Primary predicate device: 900RD010 - Fisher & Paykel’s S/USE RESUS KIT W/O MSK (10), cleared via K892885 Secondary predicate device: VentStar Helix heated (N) Plus (MP02608), cleared via K222822… | 1989 |
| * | K222822 | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)Summary page 5…MSK (10), cleared via K892885 Secondary predicate device: VentStar Helix heated (N) Plus (MP02608), cleared via K222822 Reference device for VentStar MU10841 Breathing hose for Resuscitaire with Autobreath heated (N): AutoBreath, disp… | 2023 |
| † | K120642 | Resuscitaire with Autobreath | 2012 |
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 33 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 15 ancestors have a recall of any class.
- 11 other devices also cite its predicate K892885.
How does its category compare?
All BTL devicesBTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · BTL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTL
203in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTL
2in 2024
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · BTL
165in 2025
MAUDE reports naming product code BTL, 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 | 5 | 122 | 1 | 5 |
| 2008 | 4 | 198 | 0 | 37 |
| 2009 | 5 | 173 | 0 | 69 |
| 2010 | 3 | 140 | 0 | 96 |
| 2011 | 2 | — | 1 | 75 |
| 2012 | 0 | — | 2 (2) | 115 |
| 2013 | 1 | — | 3 (1) | 103 |
| 2014 | 7 | 203 | 0 | 70 |
| 2015 | 1 | — | 3 (2) | 79 |
| 2016 | 0 | — | 0 | 80 |
| 2017 | 2 | — | 0 | 101 |
| 2018 | 1 | — | 0 | 197 |
| 2019 | 1 | — | 3 (3) | 341 |
| 2020 | 1 | — | 0 | 454 |
| 2021 | 1 | — | 1 | 506 |
| 2022 | 0 | — | 0 | 755 |
| 2023 | 1 | — | 0 | 731 |
| 2024 | 0 | — | 2 (2) | 667 |
| 2025 | 1 | — | 0 | 165 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
VentStar Resus heated (N) (MP17030): VentStar Resus heated (N) with manual PEEP valve is a disposable breathing circuit for conveying breathing gas from a breathing gas source (resuscitation module) via the Fisher & Paykel MR850 humidifier to a patient. The product allows short-term ventilation with humidified breathing gas and additional PEEP. It can be connected to a breathing mask, a laryngeal mask, or an endotracheal tube via the patient port. The…
Read the full statement (186 words)
VentStar Resus heated (N) (MP17030):
VentStar Resus heated (N) with manual PEEP valve is a disposable breathing circuit for conveying breathing gas from a breathing gas source (resuscitation module) via the Fisher & Paykel MR850 humidifier to a patient.
The product allows short-term ventilation with humidified breathing gas and additional PEEP.
It can be connected to a breathing mask, a laryngeal mask, or an endotracheal tube via the patient port.
The product is suitable for patients with a maximum body weight of 10 kg (22 lb).
VentStar Autobreath heated (N) (MP17031):
VentStar AutoBreath heated (N) with automatic PEEP valve is a disposable breathing circuit for conveying breathing gas from a breathing gas source resuscitation module) via the Fisher & Paykel MR850 humidifier to a patient.
The product allows automatic short-term ventilation with humidified breathing gas and additional PEEP.
The valve is controlled via the AutoBreath function of the resuscitation module. The product can be connected to a breathing mask, a laryngeal mask, or an endotracheal tube via the patient port.
The product is suitable for patients with a maximum body weight of 10 kg (22 lb).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242769 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242769: VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242769
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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