Skip to content

DC-4 Shunt Infusion T

by Akcess Medical Products, Inc.

510(k) K891754

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 NumberK891754 Date7 Apr 1989ClearedStatusActive

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  • Withdrawn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
FKB
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 DC-4 Shunt Infusion T is a connector device used in medical applications. It is classified as a Connector, Blood Tubing, Infusion T and is intended for use in gastroenterology and urology procedures.

The device is supplied by Akcess Medical Products, Inc. and has FDA 510(k) clearance with product code FKB. It is a Class II medical device and is regulated under number 876.5820. The device is available in the DC-4 model and is not specified as single-use or reusable in the provided data.

Other devices from Akcess Medical Products, Inc.

See all devices from Akcess Medical Products, Inc. →

Questions

AI-generated answers, 27 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 DC-4 Shunt Infusion T used for?

    The DC-4 Shunt Infusion T is a connector device specifically designed for use in gastroenterology and urology procedures. It functions as a blood tubing infusion T connector to facilitate medical applications in these specialties.

  • How is the DC-4 Shunt Infusion T supplied?

    The DC-4 Shunt Infusion T is supplied by Akcess Medical Products, Inc. The device is available in the DC-4 model, though the provided data does not specify whether it is single-use or reusable.

  • What is the regulatory status of the DC-4 Shunt Infusion T?

    The DC-4 Shunt Infusion T has FDA 510(k) clearance with product code FKB. It is classified as a Class II medical device regulated under number 876.5820. The device received traditional clearance on April 7, 1989.

  • Are there different sizes or models of the DC-4 Shunt Infusion T available?

    The provided data indicates the DC-4 Shunt Infusion T is available in the DC-4 model. No other sizes or models are mentioned in the device specifications.