# K012947: Smartflow

- Pathway: 510(k) (Special)
- Applicant: Florence Medical, Ltd.
- Decided: Oct 2, 2001 after 28 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- 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 K003122 (2001). 1 ancestor in all.
48 later devices descend from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003122: Smartflow, Model Sfip 2000, Florence Medical, Ltd. (2001) Summary page 1.

## Most influential descendants
- K020127: Smartflow Pulse Transmission Coefficient (2002), 47 descendants of its own
- K022188: Radianalyzer, Model 12710 (2002), 46 descendants of its own
- K042628: Modification to: Radianalyzer, Model 12711 (2005), 26 descendants of its own
- K031662: Pressure Wire Sensor, Models 12004/12304 (2003), 26 descendants of its own
- K092105: Radianalyzer Xpress (2009), 25 descendants of its own

## Indications for use
The SmartFlow™ is intended for use in coronary and peripheral vasculature in conjunction with pressure measurement devices during and after diagnostic procedures, such as angiography, or interventional procedures, such as angioplasty, to evaluate the hemodynamic status of the diseased arteries and to provide further clinical information in the diagnosis and treatment of both coronary and peripheral artery diseases.

Source page: https://510kreport.com/device/K012947
Methodology: https://510kreport.com/methodology