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Plexus Pulser I, Plexus Pulser II

by Dobre, Inc. 510(k)

Active United States

510(k) K924891

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK924891 Date7 Jun 1993ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JOW
Device Class
Class II
Regulation
21 CFR Part 870.5800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 device is a Sleeve, Limb, Compressible, classified under cardiovascular medical specialty. It is identified as substantially equivalent to a predicate device under FDA 510(k) clearance.

It was cleared via the traditional 510(k) pathway with K number K924891, received on September 28, 1992, and cleared on June 7, 1993. The device is manufactured by Dobre, Inc. in Kettering, Ohio, and is associated with multiple FEI and registration numbers as listed in the specifications.

Other devices from Dobre, Inc.

Questions

AI-generated answers, 23 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 PLEXUS PULSER I and II device used for?

    The PLEXUS PULSER I and II are compressible limb sleeves designed for cardiovascular medical applications, intended to provide external compression to limbs as part of circulatory support or therapy, based on their classification as a Sleeve, Limb, Compressible device under cardiovascular specialty.

  • How is the PLEXUS PULSER I and II supplied and is it sterile or reusable?

    The device data does not specify sterility, single-use, or reusable status, nor does it detail packaging or supply format; therefore, no conclusion can be drawn about its supply method or reusability from the provided information.

  • What sizes or models are available for the PLEXUS PULSER I and II?

    The device is identified as two models: PLEXUS PULSER I and PLEXUS PULSER II, but no specific sizes, dimensions, or variations for either model are provided in the device data.

  • What are the storage requirements for the PLEXUS PULSER I and II?

    Storage conditions are not specified in the device data; no information about temperature, humidity, or environmental storage limits is available for this device.

  • What regulatory pathway was used for the PLEXUS PULSER I and II?

    The PLEXUS PULSER I and II received FDA 510(k) clearance through the traditional pathway, with K number K924891, based on a determination of substantial equivalence to a predicate device, and was cleared on June 7, 1993.