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The Circulator Boot

by Circulator Boot Corp. 2 variants

510(k) K971026

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK971026 Date14 Aug 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DRN
Device Class
Class II
Regulation
21 CFR Part 870.5225
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Circulator Boot is an external, counter-pulsating device classified under regulation number 870.5225 and product code DRN. It is a cardio-synchronous compression system designed to provide intermittent compression therapy.

The device is supplied as a system including a rapid action valve assembly capable of pressurizing and exhausting the boot within a fraction of a second. It received traditional 510(k) clearance (K971026) from the FDA in 1997 and is classified as a Class II device for cardiovascular use.

Other devices from Circulator Boot Corp.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is THE CIRCULATOR BOOT used for?

    THE CIRCULATOR BOOT is a cardio-synchronous compression system designed to provide intermittent compression therapy. It functions as an external, counter-pulsating device intended for cardiovascular use, delivering timed pressure to assist circulation in synchronization with the cardiac cycle.

  • How is THE CIRCULATOR BOOT supplied and what components does it include?

    THE CIRCULATOR BOOT is supplied as a complete system that includes a rapid action valve assembly capable of pressurizing and exhausting the boot within a fraction of a second. This enables the counter-pulsating action required for intermittent compression therapy.

  • Is THE CIRCULATOR BOOT a single-use or reusable device?

    THE CIRCULATOR BOOT is designed as a reusable external device. It is supplied as a system with a rapid action valve assembly and boot intended for repeated use in clinical settings, with no indication in the provided data that it is single-use or disposable.

  • What regulatory pathway was used for THE CIRCULATOR BOOT and what is its classification?

    THE CIRCULATOR BOOT received traditional 510(k) clearance (K971026) from the FDA in 1997 and is classified as a Class II device for cardiovascular use, based on its substantial equivalence to a predicate device under regulation number 870.5225 and product code DRN.