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DURHAM - Durham

by Intl. Medical Consultants

510(k) K930927

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 NumberK930927 Date3 Nov 1993ClearedStatusActive

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  • Withdrawn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
FPA
Models / Variants
Durham
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Durham;T Adaptor Extensionset W/Injection Site is a medical device classified under product code FPA. It is designed as an adaptor extension set with an injection site for use in hospital settings.

This device is supplied by Intl. Medical Consultants and has received FDA 510(k) clearance with K number K930927. It is a Class 2 device cleared through the Traditional 510(k) pathway and is intended for general hospital use.

Other devices from Intl. Medical Consultants

Questions

AI-generated answers, 26 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 Durham;T Adaptor Extension Set with Injection Site used for?

    It is designed as an adaptor extension set with an injection site for use in hospital settings, allowing for fluid administration and medication delivery through a connected system.

  • How is the Durham;T Adaptor Extension Set supplied and is it sterile?

    The device is supplied by Intl. Medical Consultants as a ready-to-use extension set with an integrated injection site; however, the provided data does not specify sterility status, so users should consult labeling for sterilization and handling instructions.

  • Is the Durham;T Adaptor Extension Set intended for single-use or reuse?

    The device data does not indicate whether the Durham;T Adaptor Extension Set is designated for single-use or reuse; therefore, reuse decisions must be based on the manufacturer’s labeling and institutional reprocessing policies.

  • What regulatory pathway was used for the Durham;T Adaptor Extension Set?

    It received FDA 510 510(k) clearance through the Traditional 510(k) pathway, with K number K930927, and was found substantially equivalent to a predicate device under product code FPA.