# K970840: Intelliflow Respiratory Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Simtec, Inc.
- Decided: Nov 26, 1997 after 264 days
- Product code: BZC (Calculator, Pulmonary Function Data)
- Device class: 2
- Regulation: 21 CFR 868.1880
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The SIMTEC Intelliflow Respiratory Analyzer is intended to acquire and interpret pulmonary function data and for CO_ analysis. The Intelliflow unit was tested at LDS Hospital to verify that it conforms to the 24 wave forms recommended by the American Thoracic Society Standard of Spirometry, Am. Rev. Respir. Dis. 1987;136, 1285-1298. The Intelliflow does not meet the ATS guidelines for accuracy. The following five wave forms have not been qualified for accuracy according to the LFS simulator: #3FVC, #15MMEF, #21FVC, #23FVC, #24FVC. A copy of the actual results is enclosed with the operator's manual. Please contact SIMTEC for an explanation of the differences in the LDS simulator results and the method used by SIMTEC to verify the accuracy of all 24 wave forms. This device is not intended for patient monitoring.

Source page: https://510kreport.com/device/K970840
Methodology: https://510kreport.com/methodology