# K973644: Flostat Vascular Lab

- Pathway: 510(k) (Traditional)
- Applicant: Biomedix, Inc.
- Decided: Dec 23, 1997 after 90 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.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices 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.

## Most influential descendants
- K042616: Biomedix Padnet Lab (2004), 5 descendants of its own
- K073146: Padnet+ (2007), 2 descendants of its own
- K122281: Padnet 2.0 (2012), 1 descendant of its own
- K220527: PADnet Xpress (2022), 0 descendants of its own
- K103693: Vantage Abi (2011), 0 descendants of its own

## Indications for use
The BioMedix, Inc. Flostat Vascular Lab is a device for the use in the diagnosis of the etiology and extent of vascular pathology primarily in the peripheral vasculature and, in a more restricted sense, in the central vasculature (periorbital region ONLY). These tasks are accomplished via three separate modalities, each of which can be use to test either the arterial or venous system. The three modalities are 1) Pneumoplethysmography (blood pressure cuff air inflation), 2) Photoplethysmography (change in infrared light reflectance on skin as a reflection of larger branches) and 3) Simple continuous wave doppler ultrasound velocity waveform measurement. NONE of these testing modalities are intended for FETAL USE and the devices and instruction manuals are so labelled. The air pump Pneumoplethysmograph and infrared Photoplethysmograph are for use in studying the PERIPHERAL VASCULATURE ONLY. The 5 MHz. continuous wave doppler ultrasound velocity meter and the 8 MHz. continuous wave doppler ultrasound velocity meter are for use in studying the PERIPHERAL VASCULATURE ONLY. There is a separate control setting labelled clearly on the FLOSTAT VASCULAR LAB - ‘Ophthalmic-8 MHz.’ doppler which is intended for periorbital doppler studies ONLY. The ‘Ophthalmic-8 MHz.’ mode is an 8 MHz. continuous wave doppler ultrasound velocity meter exactly the same as the 8 MHz. continuous wave doppler velocity meter except that the ‘Ophthalmic-8 MHz.’ doppler has substantially lower acoustic output which conforms to the safety standards for periorbital studies specified by the Food and Drug Administration (FDA). Through medical studies performed by the scientists at the FDA, it has been determined that ultrasound acoustic levels as rated by various figures of merit (eg ISPTA, etc.) are safe for different areas of the body. For this reason, DO NOT EVER PERFORM PERIORBITAL STUDIES WITH THE DOPPLER IN ANY MODE OTHER THAN THE ‘Ophthalmic-8 MHz.’ MODE. Labels will also be placed on the doppler transducer that they are NOT FOR FETAL USE and specifying the correct frequency (5 MHz or 8 MHz). The doppler section is intended to generate velocity waveforms and values for study and audio output for physician analysis of the arterial and venous system. The Ultrasonic Doppler device at 5 MHz. and 8 MHz. applies ultrasound energy through the extremities of the subject to assess blood velocity, blood velocity waveform morphology, spectrum analysis, pressure, and patency of PERIPHERAL VESSELS. The Ultrasonic Ophthalmic-8 MHz. device applies ultrasound energy to the periorbital region to assess blood velocity, blood velocity waveform morphology, and spectrum analysis in this area. The Pneumoplethysmograph is used to gauge the arterial system through volume pulse recording studies and is used to gauge the venous system through maximum venous outflow studies. The Photoplethysmograph is used to gauge the arterial system through pulse waveform analysis and is used to gauge the venous system through venous reflux time tests. Full clinical information is provided in the Operators Instruction Manual (enclosed herein).

Source page: https://510kreport.com/device/K973644
Methodology: https://510kreport.com/methodology