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A-V Mini Clinic

by Instromedix, Inc.

510(k) K800405

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK800405 Date21 Jul 1980ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
DRT
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 A-V Mini Clinic is a Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) device classified under product code DRT and regulation number 870.2300. It is a Class II medical device in the cardiovascular specialty, substantially equivalent to a predicate device as determined by FDA 510(k) clearance K800405.

Manufactured by Instromedix, Inc. in Mchenry, Illinois, US, the device received FDA 510(k) clearance on July 21, 1980, following a traditional review process. It is not third-party reviewed and is identified by the openFDA FEI numbers listed in the specifications.

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Questions

AI-generated answers, 19 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 A-V Mini Clinic intended to monitor?

    The A-V Mini Clinic is a cardiac monitor that includes a cardiotachometer and rate alarm, designed to monitor heart activity as part of cardiovascular care.

  • How was the A-V Mini Clinic cleared for marketing in the United States?

    The A-V Mini Clinic received FDA 510(k) clearance through a traditional review process on July 21, 1980, under clearance number K800405, based on substantial equivalence to a predicate device.

  • What regulatory classification and product code apply to the A-V Mini Clinic?

    The A-V Mini Clinic is classified as a Class II medical device with product code DRT, falling under regulation number 870.2300 in the cardiovascular specialty.

  • Who manufactures the A-V Mini Clinic and where is it produced?

    The A-V Mini Clinic is manufactured by Instromedix, Inc. in McHenry, Illinois, United States, as indicated in the device specifications and authorization data.

  • Is the A-V Mini Clinic subject to third-party review?

    No, the A-V Mini Clinic was not third-party reviewed; it underwent a traditional FDA 510(k) review process, as indicated by the third_party_flag field set to 'N'.