# K093192: Flochec Photo Plethysmographic Device

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Vascular Dynamics
- Decided: Feb 12, 2010 after 126 days
- Product code: JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic)
- Device class: 2
- Regulation: 21 CFR 870.2780
- 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 K944495 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982707: EC6 Plethysmograph, D. E. Hokanson, Inc. (1998) Summary page 1.
- K944495: Model 3200 Vascular Mini-Lab, Parks Medical Electronics, Inc. (1995) Summary page 1.

## Most influential descendants
- K143094: QuantaFlo (2015), 0 descendants of its own

## Indications for use
To monitor relative blood flow changes distal to the occlusion of a brachial, radial, ulnar, or femoral artery. From the physician history and clinical findings, the person has pain, claudication, or changes in blood flow to the extremity. The device is for adult use and not for pediatric or fetal use.

Source page: https://510kreport.com/device/K093192
Methodology: https://510kreport.com/methodology