510(k) · Cleared
Cleared731 Series Ventilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ZOLL Medical Corporation · CBK Ventilator, Continuous, Facility Use
Cleared on Dec 13, 2024 as substantially equivalent to K162832 (ZOLL Medical Corporation, 2017) after a 413-day review. Its family tree reaches back 14 generations to 1991. 14 of the 131 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 13, 2024
- Review
- 413 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K902859 (1991). 130 ancestors in all, the oldest K833982 (1984). No later device cites it as a predicate yet. 14 of the 131 devices in this family, counting this one, have a Class I recall.
- Root · 14 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 10 generations between
- 3 generations backK083693 PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc. · 2009
- 2 generations backK103211 Avea VentilatorCare Fusion · 2011 · Recalled (Class I)
- 1 generation backK162832 731 Series VentilatorsZOLL Medical Corporation · 2017 · Recalled (Class I)
- This deviceK233486 731 Series VentilatorZOLL Medical Corporation · 2024
Show all 14 generations
- Root · 14 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 13 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 12 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 11 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 10 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 9 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 8 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 7 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 6 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 5 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 4 generations backK073179 Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option…Maquet Critical Care AB · 2008
- 3 generations backK083693 PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc. · 2009
- 2 generations backK103211 Avea VentilatorCare Fusion · 2011 · Recalled (Class I)
- 1 generation backK162832 731 Series VentilatorsZOLL Medical Corporation · 2017 · Recalled (Class I)
- This deviceK233486 731 Series VentilatorZOLL Medical Corporation · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −13 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −12 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −11 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −10 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −9 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −8 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −7 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −6 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −5 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| −4 | K073179 | Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585 | Maquet Critical Care AB | 2008 | — |
| −3 | K083693 | PB 840 Ventilator System with Leak Compensation Option, Model 840 | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2009 | — |
| −2 | K103211 | Avea Ventilator | Care Fusion | 2011 | Class I |
| −1 | K162832 | 731 Series Ventilators | ZOLL Medical Corporation | 2017 | Class I |
| 0 (this device) | K233486 | 731 Series Ventilator | ZOLL Medical Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 3 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 6 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 13 | 3 |
| 1999 | 9 | 0 |
| 2000 | 5 | 1 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 1 |
| 2004 | 12 | 1 |
| 2005 | 5 | 0 |
| 2006 | 6 | 1 |
| 2007 | 2 | 1 |
| 2008 | 4 | 1 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 2 |
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.
14 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 |
|---|---|---|---|
| * | K162832 | 731 Series VentilatorsSummary page 5…Ventilator Classification Name: Continuous Ventilator (21 CFR 868.5895) Product Code: CBK, DQA Predicate Device: 731 Series Ventilators (K162832, cleared 08/02/2017) Regulation Number: 868.5895 Regulatory Class: Class II Product Code: CBK, DQA… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (14 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.
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 2 generations back · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
- K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc. · 2012 · 2 generations back · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
- K103211Avea VentilatorCare Fusion · 2011 · 2 generations back · ◆ on the line of descent in FIG. 114 Class I recalls
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 2 generations back · ◆ in the 2007 ancestors bar of FIG. 12 Class I recalls
- K062267Oxylog 3000Drager Medical B.V. · 2006 · 4 generations back · ◆ in the 2006 ancestors bar of FIG. 13 Class I recalls
- K013642AVEABird Products Corp. · 2002 · 4 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
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 5 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 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
Nearest 12 of 14 shown.
Nearest 5 of 14; all are on the web page.
What does this lineage say?
- The line of descent spans 33 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- 45 of the 130 ancestors have a recall of any class; 14 have a Class I recall.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Ventilation Each model of the ZOLL 731 Series of Ventilators is indicated for use in the management of infant through adult patients weighing greater than or equal to 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. ZOLL Ventilators are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust…
Read the full statement (227 words)
Ventilation
Each model of the ZOLL 731 Series of Ventilators is indicated for use in the management of infant through adult patients weighing greater than or equal to 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. ZOLL Ventilators are appropriate for use in hospitals, outside the hospital, during transport and in severe 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. When marked with an "MRI conditional" label, ZOLL ventilators are suitable for use in an MRI environment with appropriate precautions. ZOLL 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.
Pulse Oximetry (Sp02)
The ZOLL Ventilator pulse oximeter with Masimo SET technology is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02), and pulse rate. The pulse Sp02 oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233486 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233486: 731 Series Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233486
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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