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Circulator Miniboot

by Circulator Boot Corp.

510(k) K833627

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 NumberK833627 Date23 May 1984ClearedStatusActive

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  • Withdrawn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, 21 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 Miniboot is a device, counter-pulsating, external, classified under product code DRN and regulation number 870.5225. It is a cardio-synchronous compression system classified as intermittent compression therapy (ICT).

The device includes a rapid action valve assembly capable of both pressurizing and exhausting the boot within a fraction of a second. It received FDA 510(k) clearance K833627 on May 23, 1984, and is manufactured by Circulator Boot Corp. in Walker, MI.

Other devices from Circulator Boot Corp.

Questions

AI-generated answers, 21 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 Miniboot used for?

    The Circulator Miniboot is an external counter-pulsating compression device designed for intermittent compression therapy (ICT). It functions as a cardio-synchronous system, meaning its compression cycles are timed with the patient's heart rhythm to support cardiovascular treatment.

  • How is the device supplied?

    The device is supplied by Circulator Boot Corp., based in Walker, MI. It is manufactured in the United States and distributed as a complete system including the rapid action valve assembly necessary for pressurizing and exhausting the boot.

  • Is the device single-use or reusable?

    The device data does not specify whether the Circulator Miniboot is single-use or reusable. This information would typically be found in the manufacturer's labeling or user manual, which is not included in the provided regulatory data.

  • What sizes and models are available?

    The provided device data lists only the CIRCULATOR MINIBOOT model. No additional sizes, variations, or alternative models are specified in the regulatory submission records.

  • How should the device be stored?

    Storage conditions for the Circulator Miniboot are not detailed in the available device data. For proper storage guidelines, including temperature, humidity, and handling requirements, users should refer to the manufacturer’s official instructions for use.