# K082134: Circulator Boot

- Pathway: 510(k) (Traditional)
- Applicant: Circulator Boot Corp.
- Decided: May 7, 2009 after 282 days
- Product code: DRN (Device, Counter-Pulsating, External)
- Device class: 2
- Regulation: 21 CFR 870.5225
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K940264 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K792354: The Circulator Boot, Circulator Boot Corp. (1980) Summary page 1.
- K833627: Circulator Miniboot, Circulator Boot Corp. (1984) Summary page 1.
- K971026: The Circulator Boot, Circulator Boot Corp. (1997) Summary page 1.
- K020857: Eecp Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation Eecp MC-2 External Counter, Vasomedical, Inc. (2002) Summary page 2.
- K022107: Cardiassist Counterpulsation System, Model Mark 3000, Cardiomedics, Inc. (2002)

## Indications for use
2008 Indications and Contraindications for the Circulator Boot Systems "Indications: The Circulator Boot System alone - or in combination with other drug or device therapies - may be prescribed by the physician to treat: Poor arterial flow in extremities associated with: · Ischemic ulcers · Rest pain or claudication (pain with walking) * Threatened gangrene * Insufficient blood supply at an amputation site · Persisting ischemia after embolectomy or bypass surgery * Pre- and post-arterial reconstruction to improve runoff Diabetes complicated by the above or other conditions possibly related to arterial insufficiency including: · Nocturnal leg cramps * Necrobiosis diabeticorum Venous diseases (once risk of emboli minimized): · Prophylaxis of deep vein thrombophlebitis · Edema and induration associated with chronic venous stasis · Venous stasis ulcers Athletic injuries: "Charlie horses", pulled muscles, and edematous muscles

Source page: https://510kreport.com/device/K082134
Methodology: https://510kreport.com/methodology