510(k) · Cleared
ClearedEvolution 3E Ventilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Event Medical, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Dec 18, 2012 as substantially equivalent to K072590 (Event Medical, Inc., 2008) after a 364-day review. Its family tree reaches back 8 generations to 1991. 2 of the 32 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 18, 2012
- Review
- 364 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K902859 (1991). 31 ancestors in all, the oldest K833982 (1984). No later device cites it as a predicate yet. 2 of the 32 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 7 generations backK961687 EVITA 4Drager, Inc. · 1996
- 6 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 5 generations backK984379 Nellcor Puritan Bennett, 760 Ventilator SystemPuritan Bennett Corp. · 1998 · Recalled
- 4 generations backK021112 Inspiration Ventilator SystemeVent Medical, Ltd. · 2002
- 3 generations backK030341 Modification to Inspiration Ventilator SystemeVent Medical, Ltd. · 2004
- 2 generations backK051550 Inspiration Ventilator SystemeVent Medical, Ltd. · 2005 · Recalled
- 1 generation backK072590 Inspiration; Ventilator System, LS Ventilator System, Infant…Event Medical, Inc. · 2008
- This deviceK113743 Evolution 3E VentilatorEvent Medical, Inc. · 2012
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −7 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −6 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −5 | K984379 | Nellcor Puritan Bennett, 760 Ventilator System | Puritan Bennett Corp. | 1998 | 4 |
| −4 | K021112 | Inspiration Ventilator System | eVent Medical, Ltd. | 2002 | — |
| −3 | K030341 | Modification to Inspiration Ventilator System | eVent Medical, Ltd. | 2004 | — |
| −2 | K051550 | Inspiration Ventilator System | eVent Medical, Ltd. | 2005 | 1 |
| −1 | K072590 | Inspiration; Ventilator System, LS Ventilator System, Infant Ventilator System… | Event Medical, Inc. | 2008 | — |
| 0 (this device) | K113743 | Evolution 3E Ventilator | Event Medical, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 1 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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.
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? (1)
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…evices are: Table I1- Predicate Devices Manufacturer/Product 510(k) Classification eVent Medical K072590 Class 11 lnspirationTM Ventilator System Continuous Ventilator… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 3 generations back · ◆ on the line of descent in 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
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 10 of the 31 ancestors have a recall of any class; 2 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. 2012, 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 eVolution 3e ventilator is intended for and designed to provide continuous and or intermittent mechanical ventilation to patients requiring ventilatory support through invasive or non-invasive interfaces and is suitable for use in the ICU, sub acute, long-term acute care, rehabilitation, and emergency room venues. This product is intended for a wide range of patients from pediatric to adult having body weights in the range of 5 kg (11 Ilb) or more…
Read the full statement (123 words)
The eVolution 3e ventilator is intended for and designed to provide continuous and or intermittent mechanical ventilation to patients requiring ventilatory support through invasive or non-invasive interfaces and is suitable for use in the ICU, sub acute, long-term acute care, rehabilitation, and emergency room venues.
This product is intended for a wide range of patients from pediatric to adult having body weights in the range of 5 kg (11 Ilb) or more who require pressure-based or volume-based continuous respiratory support, as prescribed by an attending physician.
The eVolution 3e ventilator system is a class Ilb medical device to-be used by trained and qualified healthcare professionals in hospitals or healthcare facilities and intended for sale by or on the order of a physician only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113743: Evolution 3E Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113743
Report an extraction error
Are you the manufacturer?
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