# K973857: Flostat Vascular Report Generator (VRG)

- Pathway: 510(k) (Traditional)
- Applicant: Biomedix, Inc.
- Decided: Dec 29, 1997 after 81 days
- Product code: JAF (Monitor, Ultrasonic, Nonfetal)
- Device class: 2
- Regulation: 21 CFR 892.1540
- 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 BioMedix, Inc. Flostat Vascular Report Generator is a device for the use to display the outputs from three strip chart recorder based peripheral vascular diagnostic instruments on a PC printer. In essence, this is changing one printer for another. This generic device can be used to input a signal from any device into a computer but is intended solely for use in conjunction with peripheral diagnostic instruments. Blood pressures, displayed digitally, may be recorded with the original cuffs provided by the original manufacturer. No change in equipment or technique is warranted. The three target devices are the Imex Corp. 3000 Series, 301 Series, and The Life Sciences Corp./HealthWatch PVR Series diagnostic devices. All these incorporate analog or digital pen strip chart recorders to display the output waveforms. The sole use of the VRG is to display the waveforms on the PC printer. The lowest resolution dot matrix printer with 90x90 dots per inch (and certainly much higher resolution laser printers) has a much higher resolution than the relatively meager 100 Hz bandwidth that an analog pen recorder can provide. No alterations in the clinical instructions, indications, methodologies, or outcomes will occur. The VRG is simply connected to an analog output path on the target device. The VRG is then connected (via a high ESD rated RS-232 driver) to the computer. The waveforms are brought into the computer and the opportunity is provided for printing to a printer. The intended use of the VRG-Vascular Diagnostic Unit tandem is the same as the original intended use of the original vascular diagnostic unit (i.e. peripheral vascular studies). The BMX Vascular Report Generator passes the output information of a peripheral vascular device to a computer and then onto a printer. All outputs of a peripheral vascular device, through the VRG, can be displayed, including data that can be shown as a spectrum analysis. The Vascular Report Generator does not change the output of a peripheral vascular device but only allows the computer to display the information in various forms.

Source page: https://510kreport.com/device/K973857
Methodology: https://510kreport.com/methodology