510(k) · Cleared
ClearedInfrasonics Adult Ventilator Trending Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nellcor Puritan Bennett, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Feb 14, 1997 after a 93-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Feb 14, 1997
- Review
- 93 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK964543 Infrasonics Adult Ventilator Trending OptionNellcor Puritan Bennett, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK041412 Esprit Ventilator with Nico-Esprit Interface Option, Model V1000Respironics California, Inc. · 2004 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K041412Esprit Ventilator with Nico-Esprit Interface Option, Model V1000Respironics California, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964543 | Infrasonics Adult Ventilator Trending Option | Nellcor Puritan Bennett, Inc. | 1997 | — |
| +1 | K041412 | Esprit Ventilator with Nico-Esprit Interface Option, Model V1000 | Respironics California, Inc. | 2004 | 6 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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.
Planning a device in CBK? 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? (2)
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 |
|---|---|---|---|
| * | — | Puritan Bennett Graphics 2.0 option for the Puritan-Bennett 7200 ventilator Named without a submission number | |
| * | — | Bird Products Corp. Graphic Monitor Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041412 | Esprit Ventilator with Nico-Esprit Interface Option, Model V1000 | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K041412 (Respironics California, Inc., 2004) has gone furthest, with 0 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?
This product is to be used only in conjunction with the Adult Star Model ventilator. It provides a monitoring function only and therefore has no direct interaction with ventilator function. The Trending option will periodically sample ventilator data to be used as trended parameters. This option is intended for the operator to track a total of 54 patient and ventilator parameters over a maximum time period of 72 hours. Three trended parameters can be…
Read the full statement (167 words)
This product is to be used only in conjunction with the Adult Star Model ventilator. It provides a monitoring function only and therefore has no direct interaction with ventilator function. The Trending option will periodically sample ventilator data to be used as trended parameters. This option is intended for the operator to track a total of 54 patient and ventilator parameters over a maximum time period of 72 hours. Three trended parameters can be displayed simultaneously. A cursor can then be used scan the trended dated to determine the time and magnitude of a particular occurrence or change in a monitored function. In addition, Patient data such as name, weight, clinician identification, and blood gas test data can be manually inputted. The Trending option allows real-time pressure, flow, and volume waveforms to be saved and recalled for comparison to subsequent waveforms. Pressure/Volume and Flow/Volume loops can also be saved and recalled for subsequent comparisons. A hardcopy print out can be made of all saved and trended data.
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/K964543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964543: Infrasonics Adult Ventilator Trending Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964543
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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