510(k) · Cleared
ClearedHelontix Vent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linde Gas Therapeutics · CBK Ventilator, Continuous, Facility Use
Cleared on Oct 15, 2008 as substantially equivalent to K970460 (Puritan Bennett Corp., 1998) and 2 other predicates after a 366-day review. Its family tree reaches back 7 generations to 1991. 4 of the 37 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 15, 2008
- Review
- 366 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K902859 (1991). 36 ancestors in all, the oldest K895541 (1990). No later device cites it as a predicate yet. 4 of the 37 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 6 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 5 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 4 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 3 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 2 generations backK022674 Bird Avea VentilatorBird Products Corp. · 2002 · Recalled
- 1 generation backK041524 GE Datex-Ohmeda Heliox Delivery SystemDatex-Ohmeda, Inc. · 2004
- This deviceK072926 Helontix VentLinde Gas Therapeutics · 2008
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −6 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −5 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −4 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −3 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −2 | K022674 | Bird Avea Ventilator | Bird Products Corp. | 2002 | 5 |
| −1 | K041524 | GE Datex-Ohmeda Heliox Delivery System | Datex-Ohmeda, Inc. | 2004 | — |
| 0 (this device) | K072926 | Helontix Vent | Linde Gas Therapeutics | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 1 |
| 1999 | 2 | 0 |
| 2000 | 3 | 1 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 1 |
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.
4 devices in this family have a Class I recall. 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 CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 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 |
|---|---|---|---|
| * | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Summary page 1…Helontix Vent Identification of predicate device(s): Puritan Bennett 840 Ventilator System K970460 GE Datex-Ohmeda Apta6r Heliox… | 1998 |
| * | K041524 | GE Datex-Ohmeda Heliox Delivery SystemSummary page 1…K970460 GE Datex-Ohmeda Apta6r Heliox Delivery system, K041524 Maquet Critical Care AB, Servo-i… | 2004 |
| * | K041223 | Modification to Servo-I Ventilator System, Model 64 87 800 E407ESummary page 1…Maquet Critical Care AB, Servo-i Ventilator system NIV option, K041223 1.2 ESTABLISHMENT REGISTRATION NUMBER Will be applied for with submission and review of this 5 10(k) 1.3 ADDRESS O… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · Direct predicate · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 3 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 4 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 14 of the 36 ancestors have a recall of any class; 4 have a Class I recall.
- 6 other devices also cite its predicate K970460.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, 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 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
The Helontix Vent is designed to deliver helium/oxygen mixtures to spontaneously breathing patients via a facemask with or without pressure support. The system is designed for facility use and should only be used under the orders of a clinician.
The Helontix Vent delivery system is not intended as a life support device and is not intended for intubated patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072926 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072926: Helontix Vent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072926
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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