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Solution Transfer Container W/Attached Leg Set (Empty)

by Incutech, Inc.

510(k) K940258

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 NumberK940258 Date28 Mar 1994ClearedStatusActive

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  • Withdrawn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
KPE
Device Class
Class II
Regulation
21 CFR Part 880.5025
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Solution Transfer Container W/Attached Leg Set (Empty) is a Class II medical device designed for the storage and transfer of solutions. It is an intravenous container that comes with an attached leg set for fluid management in healthcare settings.

This device is supplied empty and is intended for single use. It is FDA 510(k) cleared with product code KPE and was cleared on March 28, 1994. The device is manufactured by Incutech, Inc. and is registered under multiple FEI numbers for general hospital use.

Other devices from Incutech, Inc.

Questions

AI-generated answers, 28 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 Solution Transfer Container W/Attached Leg Set used for?

    The Solution Transfer Container W/Attached Leg Set is a Class II medical device designed for the storage and transfer of solutions. It is an intravenous container with an attached leg set specifically intended for fluid management in healthcare settings.

  • Is the Solution Transfer Container single-use or reusable?

    The Solution Transfer Container W/Attached Leg Set is supplied empty and is intended for single use only. It should not be reused for patient safety and regulatory compliance reasons.

  • What is the regulatory status of this device?

    The Solution Transfer Container W/Attached Leg Set is FDA 510(k) cleared with product code KPE. It was cleared on March 28, 1994, and is classified as substantially equivalent to predicate devices for general hospital use.

  • Who manufactures the Solution Transfer Container W/Attached Leg Set?

    The device is manufactured by Incutech, Inc., located in Greensboro, NC. The company is registered under multiple FEI numbers for general hospital use, indicating compliance with regulatory requirements for manufacturing medical devices.