# K964543: Infrasonics Adult Ventilator Trending Option

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Feb 14, 1997 after 93 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Puritan Bennett Graphics 2.0 option for the Puritan-Bennett 7200 ventilator: named in the summary without a submission number
- (no number) Bird Products Corp. Graphic Monitor: named in the summary without a submission number

## Most influential descendants
- K041412: Esprit Ventilator with Nico-Esprit Interface Option, Model V1000 (2004), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K964543
Methodology: https://510kreport.com/methodology