# K971026: The Circulator Boot

- Pathway: 510(k) (Traditional)
- Applicant: Circulator Boot Corp.
- Decided: Aug 14, 1997 after 147 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: 1 generation back to K792354 (1980). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 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 4.
- K882683: Jobst Extremity Pump (R) System 7500, Jobst Institute, Inc. (1988) Summary page 4.
- K792430: Cardiassist External Counterpulsation, Cardiassist Corp. (1980) Summary page 4.

## Most influential descendants
- K082134: Circulator Boot (2009), 0 descendants of its own

## Indications for use
The Circulator Boot System - alone or in combination with other drug or device therapies - may be used to treat: peripheral arterial disease ischemic lesions claudication pain necrotizing cellulitis venous stasis ulcers stasis dermatitis chronic lymphedema thrombophlebitis

Source page: https://510kreport.com/device/K971026
Methodology: https://510kreport.com/methodology