# K111416: Falcon

- Pathway: 510(k) (Traditional)
- Applicant: Viasonix, Ltd.
- Decided: Jul 15, 2011 after 56 days
- Product code: JOP (Transducer, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 870.2880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904392 (1991). 2 ancestors in all.
5 later devices descend from it; 4 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)
- K002766: Nicolet Vasoguard, Nicolet Biomedical (2000) Summary page 6.
- K904392: Multilab 2000, Unetixs, Inc. (1991) Summary page 6.

## Most influential descendants
- K131623: Smartdop XT (2014), 1 descendant of its own
- K242662: Falcon/Xpress (Falcon/Xpress) (2024), 0 descendants of its own
- K233976: VasoGuard (V10, V8, V6, V4, V2) (2024), 0 descendants of its own
- K153762: Smartdop XT6 (2016), 0 descendants of its own
- K131860: Vasculab VL4000 Photoplethysmograph with Pulse Volume Recording (2013), 0 descendants of its own

## Indications for use
The Falcon/Pro, Falcon/Quad, and Falcon/ABI+ are intended for use in the noninvasive evaluation of peripheral vascular pathology in patients. The devices are not intended to replace other means of evaluating vital patient physiological processes, are not intended to be used in fetal applications, and are not intended to be used inside the sterile field. They are to be used by trained medical personnel in hospitals, clinics and physicians offices by prescription or doctor's orders.

Source page: https://510kreport.com/device/K111416
Methodology: https://510kreport.com/methodology