510(k) · Cleared
Recalled · Class I · 2024Uni-Vent (R) Model 731 Series Portable Critical Care Ventilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Impact Instrumentation, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Feb 16, 2012 as substantially equivalent to K103318 (Impact Instrumentation, Inc., 2011) after a 265-day review. Its family tree reaches back 12 generations to 1991. 7 of the 70 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 2 times, including a Class I recall.
- Decided
- Feb 16, 2012
- Review
- 265 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 2 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 12 generations to K902859 (1991). 65 ancestors in all, the oldest K861272 (1986). 4 later devices descend from it, 2 citing it directly. 7 of the 70 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 backK071526 Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc. · 2008 · Recalled
- 2 generations backK091238 Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc. · 2009 · Recalled
- 1 generation backK103318 Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2011 · Recalled
- This deviceK111473 Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK162832 731 Series VentilatorsZOLL Medical Corporation · 2017 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK122438 Hamilton-MR1Hamilton Medical AG · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK233486 731 Series VentilatorZOLL Medical Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK153046 Hamilton-MR1Hamilton Medical AG · 2016 · Recalled (Class I)
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 backK071526 Uni-Vent 731 Series Ventilators, Model 731, 731EMVImpact Instrumentation, Inc. · 2008 · Recalled
- 2 generations backK091238 Uni-Vent-731 Series Ventilators, Model 731EMV+Impact Instrumentation, Inc. · 2009 · Recalled
- 1 generation backK103318 Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2011 · Recalled
- This deviceK111473 Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2012
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · cites it directly1descendant
- K122438Hamilton-MR1Hamilton Medical AG · 2013 · cites it directly1descendant
- K233486731 Series VentilatorZOLL Medical Corporation · 2024 · 2 generations on0descendants
- K153046Hamilton-MR1Hamilton Medical AG · 2016 · 2 generations on0descendants
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 | K071526 | Uni-Vent 731 Series Ventilators, Model 731, 731EMV | Impact Instrumentation, Inc. | 2008 | 1 |
| −2 | K091238 | Uni-Vent-731 Series Ventilators, Model 731EMV+ | Impact Instrumentation, Inc. | 2009 | 1 |
| −1 | K103318 | Uni-Vent 731 Series Model Emv+ Portable Critical Care Ventilator | Impact Instrumentation, Inc. | 2011 | 2 |
| 0 (this device) | K111473 | Uni-Vent (R) Model 731 Series Portable Critical Care Ventilator | Impact Instrumentation, Inc. | 2012 | — |
| +1 | K162832 | 731 Series Ventilators | ZOLL Medical Corporation | 2017 | Class I |
| +1 | K122438 | Hamilton-MR1 | Hamilton Medical AG | 2013 | 1 |
| +2 | K233486 | 731 Series Ventilator | ZOLL Medical Corporation | 2024 | — |
| +2 | K153046 | Hamilton-MR1 | Hamilton Medical AG | 2016 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 8 | 2 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 1 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 1 |
| 2017 | 1 | 1 |
| 2024 | 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.
7 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 |
|---|---|---|---|
| * | K103318 | Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorSummary page 5…tes that these devices are as safe and Predicate effective and performs as well as or better than the Predicate device (K103318). Other Information requested Impact Instrumentation, Inc. will provide the FDA with any by FDA additi… | 2011 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (7 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 30, 2024 | Class I | Z-2130-2024 | Under Investigation by firm | Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety Ventilator MRI information omitted from the manuals. Update to the instructions ensures safe distance from the MRI to ensure… |
| Jun 30, 2017 | Class II | Z-0812-2018 | Under Investigation by firm | A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings. |
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.
- K013642AVEABird Products Corp. · 2002 · 5 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 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
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K153046Hamilton-MR1Hamilton Medical AG · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 19 of the 65 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K162832 (ZOLL Medical Corporation, 2017) has gone furthest, with 1 descendant of its own.
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 devices in the Model 731 Ventilator Series are indicated for use in the management of infant through adult patients weighing ≥5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. They are appropriate for use in hospitals, outside the hospital, during transport and in austere environments where they may be exposed to rain, dust, rough handling and extremes in temperature and…
Read the full statement (208 words)
The devices in the Model 731 Ventilator Series are indicated for use in the management of infant through adult patients weighing ≥5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. They are appropriate for use in hospitals, outside the hospital, during transport and in austere environments where they may be exposed to rain, dust, rough handling and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present (see External Filter Use). When marked with an “MRI conditional” label, they are suitable for use in an MRI environment with appropriate precautions, as defined in the Operation Manual. The Model 731 Ventilators are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation and by first responders under the direction of skilled medical care providers. The EMV+ and Eagle II (with and without MRI label) have a full range of ventilation modes (AC, SIMV, CPAP with PS and NPPV-PPV). The AEV (with and without MRI label) has a more limited range of ventilation modes for less sophisticated operators (AC, CPAP with PS and PPV).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111473 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111473: Uni-Vent (R) Model 731 Series Portable Critical Care Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111473
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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