510(k) · Cleared
Recalled · Class I · 2015Inspiration Ventilator System 5I/7I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
eVent Medical, Ltd. · CBK Ventilator, Continuous, Facility Use
Cleared on Oct 29, 2013 as substantially equivalent to K072590 (Event Medical, Inc., 2008) and 1 other predicate after a 277-day review. Its family tree reaches back 12 generations to 1991. 9 of the 107 devices in its family, counting itself, have a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Oct 29, 2013
- Review
- 277 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 12 generations to K902859 (1991). 106 ancestors in all, the oldest K791045 (1979). No later device cites it as a predicate yet. 9 of the 107 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 8 generations between
- 3 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 2 generations backK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- 1 generation backK103803 Hamilton-G5Hamilton Medical AG · 2011 · Recalled (Class I)
- This deviceK130178 Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013
Show all 12 generations
- Root · 12 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 11 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 10 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 9 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 8 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 7 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 6 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 5 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 4 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 3 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 2 generations backK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- 1 generation backK103803 Hamilton-G5Hamilton Medical AG · 2011 · Recalled (Class I)
- This deviceK130178 Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −11 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −10 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −9 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −8 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −7 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −6 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −5 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −4 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −3 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| −2 | K081842 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2008 | — |
| −1 | K103803 | Hamilton-G5 | Hamilton Medical AG | 2011 | Class I |
| 0 (this device) | K130178 | Inspiration Ventilator System 5I/7I | eVent Medical, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 6 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 12 | 3 |
| 1999 | 7 | 0 |
| 2000 | 3 | 1 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 1 |
| 2004 | 8 | 1 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2008 | 4 | 0 |
| 2010 | 2 | 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.
9 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? (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 |
|---|---|---|---|
| * | K072590 | Inspiration; Ventilator System, LS Ventilator System, Infant Ventilator System and…Summary page 1…- Predicate Devices Manufacturer/Product 510(k) Classification eVent Medical K072590 Class 11 InspirationTM Ventilator System Continuous Ventilator… | 2008 |
| * | K103803 | Hamilton-G5Summary page 1…us Ventilator per 21 CFR 868.5895 Hamilton G-5 Ventilator K103803 Class 11 Continuous Ventilator ___… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (9 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 13, 2015 | Class I | Z-0230-2016 | Component design/selection | A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming. |
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.
- K103803Hamilton-G5Hamilton Medical AG · 2011 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 5 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 6 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 7 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- The line of descent spans 22 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- 32 of the 106 ancestors have a recall of any class; 8 have a Class I recall.
- 1 other device also cites its predicate K072590.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Inspiration 7i/5i Ventilator System is intended for use with patients having body weights in the range of 0.3kg to 200kg and Tidal Volumes of 5ml to 2000ml. The Inspiration Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport. This product is intended for a wide range of patients from infant to adult and for a wide variety of clinical conditions. The intended patient population…
Read the full statement (148 words)
The Inspiration 7i/5i Ventilator System is intended for use with patients having body weights in the range of 0.3kg to 200kg and Tidal Volumes of 5ml to 2000ml. The Inspiration Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport.
This product is intended for a wide range of patients from infant to adult and for a wide variety of clinical conditions.
The intended patient population includes infant through adult patients who require pressure-based or volume-based continuous respiratory support with tidal volumes as low as 5 ml and inspiratory pressures as low as 1cm H2O.
The device is intended for use in hospitals and hospital-type facilities, which provide respiratory care for patients requiring respiratory support.
The device is intended for sale by or on the order of a physician only. The device is intended for operation by trained and qualified personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130178: Inspiration Ventilator System 5I/7I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130178
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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