510(k) · Cleared
ClearedInspiration Ventilator System
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 Nov 22, 2002 as substantially equivalent to K960010 (Siemens Elema AB, 1996) and 1 other predicate after a 231-day review. Its family tree reaches back 4 generations to 1991. 2 of the 18 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.
- Decided
- Nov 22, 2002
- Review
- 231 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K902859 (1991). 11 ancestors in all, the oldest K864394 (1986). 6 later devices descend from it, 2 citing it directly. 2 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 3 generations backK961687 EVITA 4Drager, Inc. · 1996
- 2 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 1 generation backK984379 Nellcor Puritan Bennett, 760 Ventilator SystemPuritan Bennett Corp. · 1998 · Recalled
- This deviceK021112 Inspiration Ventilator SystemeVent Medical, Ltd. · 2002
- Descendant · cites it directly · 4 of its ownK030341 Modification to Inspiration Ventilator SystemeVent Medical, Ltd. · 2004
- Descendant · 2 generations on · 3 of its ownK051550 Inspiration Ventilator SystemeVent Medical, Ltd. · 2005 · Recalled
- Descendant · 3 generations on · 2 of its ownK072590 Inspiration; Ventilator System, LS Ventilator System, Infant…Event Medical, Inc. · 2008
- Descendant · 4 generations on · 0 of its ownK130178 Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · Recalled (Class I)
- Descendant · 4 generations on · 0 of its ownK113743 Evolution 3E VentilatorEvent Medical, Inc. · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K030341Modification to Inspiration Ventilator SystemeVent Medical, Ltd. · 2004 · cites it directly4descendants
- K051550Inspiration Ventilator SystemeVent Medical, Ltd. · 2005 · 2 generations on3descendants
- K072590Inspiration; Ventilator System, LS Ventilator System, Infant Ventilator System and…Event Medical, Inc. · 2008 · 3 generations on2descendants
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 4 generations on0descendants
- K113743Evolution 3E VentilatorEvent Medical, Inc. · 2012 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −3 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −2 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −1 | K984379 | Nellcor Puritan Bennett, 760 Ventilator System | Puritan Bennett Corp. | 1998 | 4 |
| 0 (this device) | K021112 | Inspiration Ventilator System | eVent Medical, Ltd. | 2002 | — |
| +1 | K030341 | Modification to Inspiration Ventilator System | eVent Medical, Ltd. | 2004 | — |
| +2 | K051550 | Inspiration Ventilator System | eVent Medical, Ltd. | 2005 | 1 |
| +3 | K072590 | Inspiration; Ventilator System, LS Ventilator System, Infant Ventilator System… | Event Medical, Inc. | 2008 | — |
| +4 | K130178 | Inspiration Ventilator System 5I/7I | eVent Medical, Ltd. | 2013 | Class I |
| +4 | K113743 | Evolution 3E Ventilator | Event Medical, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 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.
2 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 |
|---|---|---|---|
| * | K960010 | Servo Ventilator 300 Computer InterfaceSummary page 1…rafion Ventilator System, as well as testing to accepted industry standards. The predicate devices are as follows: 1. Servo Ventilator 300, Siemens-Elema AB, K960010 2. 760 Ventilator, Puritan Bennett Inc., K984379 Section 16.e Device Description The /nspirafionTMVentilator… | 1996 |
| * | K984379 | Nellcor Puritan Bennett, 760 Ventilator SystemSummary page 1…industry standards. The predicate devices are as follows: 1. Servo Ventilator 300, Siemens-Elema AB, K960010 2. 760 Ventilator, Puritan Bennett Inc., K984379 Section 16.e Device Description The /nspirafionTMVentilator System is housed in a metallic enclosure, comprisinsi cl… | 1998 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 4 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K030341 (eVent Medical, Ltd., 2004) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K960010.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
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™ Ventilator System is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021112 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021112: Inspiration Ventilator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021112
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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