510(k) · Cleared
Recalled · Class II · 2013Nellcor Puritan Bennett, 760 Ventilator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puritan Bennett Corp. · CBK Ventilator, Continuous, Facility Use
Cleared on Dec 10, 1998 as substantially equivalent to K964540 (Puritan Bennett Corp., 1997) and 2 other predicates after a 3-day review. Its family tree reaches back 3 generations to 1991. 2 of the 18 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled 4 times.
- Decided
- Dec 10, 1998
- Review
- 3 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 3 generations to K902859 (1991). 9 ancestors in all, the oldest K864394 (1986). 8 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 · 3 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 2 generations backK961687 EVITA 4Drager, Inc. · 1996
- 1 generation backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- This deviceK984379 Nellcor Puritan Bennett, 760 Ventilator SystemPuritan Bennett Corp. · 1998
- Descendant · cites it directly · 6 of its ownK021112 Inspiration Ventilator SystemeVent Medical, Ltd. · 2002
- Descendant · 2 generations on · 4 of its ownK030341 Modification to Inspiration Ventilator SystemeVent Medical, Ltd. · 2004
- Descendant · 3 generations on · 3 of its ownK051550 Inspiration Ventilator SystemeVent Medical, Ltd. · 2005 · Recalled
- Descendant · 4 generations on · 2 of its ownK072590 Inspiration; Ventilator System, LS Ventilator System, Infant…Event Medical, Inc. · 2008
- Descendant · 5 generations on · 0 of its ownK130178 Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · Recalled (Class I)
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K021112Inspiration Ventilator SystemeVent Medical, Ltd. · 2002 · cites it directly6descendants
- K030341Modification to Inspiration Ventilator SystemeVent Medical, Ltd. · 2004 · 2 generations on4descendants
- K051550Inspiration Ventilator SystemeVent Medical, Ltd. · 2005 · 3 generations on3descendants
- K072590Inspiration; Ventilator System, LS Ventilator System, Infant Ventilator System and…Event Medical, Inc. · 2008 · 4 generations on2descendants
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −2 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −1 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| 0 (this device) | K984379 | Nellcor Puritan Bennett, 760 Ventilator System | Puritan Bennett Corp. | 1998 | — |
| +1 | K021112 | Inspiration Ventilator System | eVent Medical, Ltd. | 2002 | — |
| +2 | K030341 | Modification to Inspiration Ventilator System | eVent Medical, Ltd. | 2004 | — |
| +3 | K051550 | Inspiration Ventilator System | eVent Medical, Ltd. | 2005 | 1 |
| +4 | K072590 | Inspiration; Ventilator System, LS Ventilator System, Infant Ventilator System… | Event Medical, Inc. | 2008 | — |
| +5 | K130178 | Inspiration Ventilator System 5I/7I | eVent Medical, Ltd. | 2013 | Class I |
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 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K964540 | Nellcor Puritan Bennett, 740 Ventilator SystemSummary page 1…Bennett Corp. is claiming substantial equivalence to the following three predicate medical devices: Predicate Device 510(k) Number Classification Puritan Bennett Corp., K964540 Class I, 740 Ventilator Continuous Ventilator per 21 CFR 868.5895 Puritan Bennett Corp., K902506B Class II, 7200 Series Ventila… | 1997 |
| * | K902506 | 7200AE Microprocessor Ventilator W/Enhanced Hard.Summary page 1…Predicate Device 510(k) Number Classification Puritan Bennett Corp., K964540 Class I, 740 Ventilator Continuous Ventilator per 21 CFR 868.5895 Puritan Bennett Corp., K902506B Class II, 7200 Series Ventilator Continuous Ventilator per 21 CFR 868.5895 Puritan Bennett Corp., K970460 Class II, 840 Ventila… | 1991 |
| * | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Summary page 1…nuous Ventilator per 21 CFR 868.5895 Puritan Bennett Corp., K902506B Class II, 7200 Series Ventilator Continuous Ventilator per 21 CFR 868.5895 Puritan Bennett Corp., K970460 Class II, 840 Ventilator Continuous Ventilator per 21 CFR 868.5895 A Device Description: The device is a low-co… | 1998 |
What descends from it? (8)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 25, 2013 | Class II | Z-0822-2014 | Labeling Change Control | Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor), PN 4-072214-00 used in the Puritan Bennett" 840, and PN, G-062010-00, used in Puritan Bennett" 740, and760 ventilator systems. The Operators… |
| Jan 25, 2013 | Class II | Z-0821-2014 | Labeling Change Control | Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor), PN 4-072214-00 used in the Puritan Bennett" 840, and PN, G-062010-00, used in Puritan Bennett" 740, and760 ventilator systems. The Operators… |
| Dec 17, 2004 | Not classified | Z-0445-05 | Other | Capacitor weakness in backup alarm system might fail causing lack of backup alarm to function in the event of total power loss. |
| Dec 16, 2004 | Not classified | Z-0444-05 | Other | Wires on battery may loosen causing disconnection. |
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K021112 (eVent Medical, Ltd., 2002) has gone furthest, with 6 descendants 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.
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 760 Ventilator System is used to provide continuous ventilation to patients requiring respiratory support. This device is used for a wide range of patients from pediatric to adult and for a wide variety of clinical conditions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984379 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984379: Nellcor Puritan Bennett, 760 Ventilator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984379
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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