510(k) · Cleared
Recalled · Class I · 2022Puritan Bennett 980 Series Ventilator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · CBK Ventilator, Continuous, Facility Use
Cleared on Nov 20, 2020 as substantially equivalent to K162738 (Covidien, 2017) after a 385-day review. Its family tree reaches back 15 generations to 1991. 10 of the 80 devices in its family, counting itself, have a Class I recall. It has been recalled 17 times, including 17 Class I recalls.
- Decided
- Nov 20, 2020
- Review
- 385 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 17 (17 Class I)
- Predicates
- 1
Its longest line of descent runs back 15 generations to K902859 (1991). 79 ancestors in all, the oldest K883038 (1988). No later device cites it as a predicate yet. 10 of the 80 devices in this family, counting this one, have a Class I recall.
- Root · 15 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 11 generations between
- 3 generations backK103211 Avea VentilatorCare Fusion · 2011 · Recalled (Class I)
- 2 generations backK131252 Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · Recalled (Class I)
- 1 generation backK162738 Puritan Bennett 980 Ventilator SystemCovidien · 2017 · Recalled (Class I)
- This deviceK193056 Puritan Bennett 980 Series Ventilator SystemCovidien, LLC · 2020
Show all 15 generations
- Root · 15 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 14 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 13 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 12 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 11 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 10 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 9 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 8 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 7 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 6 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 5 generations backK073179 Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option…Maquet Critical Care AB · 2008
- 4 generations backK083693 PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc. · 2009
- 3 generations backK103211 Avea VentilatorCare Fusion · 2011 · Recalled (Class I)
- 2 generations backK131252 Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · Recalled (Class I)
- 1 generation backK162738 Puritan Bennett 980 Ventilator SystemCovidien · 2017 · Recalled (Class I)
- This deviceK193056 Puritan Bennett 980 Series Ventilator SystemCovidien, LLC · 2020
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −14 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −13 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −12 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −11 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −10 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −9 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −8 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −7 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −6 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| −5 | K073179 | Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585 | Maquet Critical Care AB | 2008 | — |
| −4 | K083693 | PB 840 Ventilator System with Leak Compensation Option, Model 840 | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2009 | — |
| −3 | K103211 | Avea Ventilator | Care Fusion | 2011 | Class I |
| −2 | K131252 | Puritan Bennett 980 Series Ventilator System | Covidien | 2014 | Class I |
| −1 | K162738 | Puritan Bennett 980 Ventilator System | Covidien | 2017 | Class I |
| 0 (this device) | K193056 | Puritan Bennett 980 Series Ventilator System | Covidien, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 9 | 3 |
| 1999 | 6 | 0 |
| 2000 | 3 | 1 |
| 2001 | 5 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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.
10 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 |
|---|---|---|---|
| * | K162738 | Puritan Bennett 980 Ventilator SystemSummary page 4…de: CBK Primary Predicate: Puritan Bennett™ 980 Series Ventilator System (K162738) Reference Device: Maquet’s Servo-U/n version 2.1 (K180098) Device Description The P… | 2017 |
| † | K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (10 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 25, 2022 | Class I | Z-0966-2022 | Under Investigation by firm | The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. Delayed awareness of alarm states may lead to delayed response or a delay of treatment, potentially resulting in hypoxia… |
| Nov 4, 2021 | Class I | Z-0345-2022 | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| Nov 4, 2021 | Class I | Z-0350-2022 | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| Nov 4, 2021 | Class I | Z-0346-2022 | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| Nov 4, 2021 | Class I | Z-0349-2022 | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| Nov 4, 2021 | Class I | Z-0351-2022 | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| Nov 4, 2021 | Class I | Z-0338-2022 | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| Nov 4, 2021 | Class I | Z-0339-2022 | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| Nov 4, 2021 | Class I | Z-0340-2022 | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| Nov 4, 2021 | Class I | Z-0343-2022 | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| Nov 4, 2021 | Class I | Z-0344-2022 | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| Nov 4, 2021 | Class I | Z-0353-2022 | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| Nov 4, 2021 | Class I | Z-0341-2022 | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| Nov 4, 2021 | Class I | Z-0342-2022 | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| Nov 4, 2021 | Class I | Z-0347-2022 | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| Nov 4, 2021 | Class I | Z-0348-2022 | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| Nov 4, 2021 | Class I | Z-0352-2022 | Reprocessing Controls | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
The 5 latest of 17 recalls; the web page lists all.
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.
- K162738Puritan Bennett 980 Ventilator SystemCovidien · 2017 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K131252Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
- K103211Avea VentilatorCare Fusion · 2011 · 3 generations back · ◆ on the line of descent in FIG. 114 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
- K013642AVEABird Products Corp. · 2002 · 5 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 6 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 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 8 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 10 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 9; all are on the web page.
What does this lineage say?
- The line of descent spans 29 years and passes through 10 companies; a new generation was cleared every 1.8 years on median.
- 24 of the 79 ancestors have a recall of any class; 9 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. 2020, 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 Puritan Bennett 980 Series Ventilator System is designed for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3kg (0.661b). It is suitable for service in hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from either an internal air compressor…
Read the full statement (122 words)
The Puritan Bennett 980 Series Ventilator System is designed for use on patient population sizes from Neonatal (NICU)
through Adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3kg (0.661b). It is
suitable for service in hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory
support using medical oxygen and compressed medical air from either an internal air compressor or external air sources to
deliver oxygen concentrations of 21% to 100%. Ventilatory support can be delivered invasively or non-invasively to
patients who require the following types of ventilator support
- Positive Pressure Ventilation, delivered invasively (via endotracheal tube or tracheotomy tube) or non-invasively (via
mask or nasal prongs)
- Assist/Control, SIMV, or Spontaneous modes of ventilation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193056: Puritan Bennett 980 Series Ventilator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193056
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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