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Diacare Monitoring System

by Healthware Corp.

510(k) K882001

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 NumberK882001 Date18 Oct 1988ClearedStatusActive

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  • Withdrawn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
NDC
Device Class
Class II
Regulation
21 CFR Part 868.1890
Advisory Committee
Anesthesiology
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 DIACARE MONITORING SYSTEM is a Calculator, Drug Dose device classified under medical specialty Anesthesiology. It is a substantially equivalent device cleared through the traditional 510(k) pathway.

The device is manufactured by Healthware Corp. and received FDA 510(k) clearance under K882001 on October 18, 1988. It is registered under regulation number 868.1890 and associated with multiple facility establishment identifiers (FEIs) and registration numbers as specified in the openFDA data.

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 DIACARE MONITORING SYSTEM used for?

    The DIACARE MONITORING SYSTEM is a Calculator, Drug Dose device intended for use in the medical specialty of Anesthesiology to assist in calculating drug doses, based on its classification and clearance description.

  • How was the DIACARE MONITORING SYSTEM cleared for market?

    The device received FDA 510(k) clearance through the traditional pathway under K882001, determined to be substantially equivalent to a predicate device, as stated in its decision description and clearance type.

  • When did the DIACARE MONITORING SYSTEM receive FDA clearance?

    The DIACARE MONITORING SYSTEM was cleared by the FDA on October 18, 1988, as indicated by the decision_date field in the device data.

  • What regulation number governs the DIACARE MONITORING SYSTEM?

    The device is registered under regulation number 868.1890, which is explicitly listed in the openfda field and specifications section of the device data.

  • Who manufactures the DIACARE MONITORING SYSTEM?

    The DIACARE MONITORING SYSTEM is manufactured by Healthware Corp., as specified in the manufacturer and applicant fields of the device data.