# K981366: Static and Dynamic Compliance, a Respiratory  Mechanics Option for the Vmax Series

- Pathway: 510(k) (Traditional)
- Applicant: Sensor Medics Corp.
- Decided: Oct 30, 1998 after 198 days
- Product code: BTY (Calculator, Predicted Values, Pulmonary Function)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) SensorMedics Vmax 2900: named in the summary without a submission number
- (no number) SensorMedics Vmax 2200: named in the summary without a submission number

## Indications for use
The indications for use are the same as the Vmax Series to which this product is an option. Quotation from the Indications for Use section of the Vmax premarket notification: “Basically, this involves performing physician-prescribed pulmonary function and metabolic testing. More-specific intended uses are shown in the table below, along with the predicate SensorMedics product model with the same intended-use labeling.” The Static and Dynamic Compliance option is indicated specifically for Evaluation of medication effects, Pulmonary Function testing in adults & children, Pulmonary disability evaluation, Industrial surveillance and Bedside lung function.

Source page: https://510kreport.com/device/K981366
Methodology: https://510kreport.com/methodology