Empty Solution Transfer Container

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K842170 ↗

FDA Product Code

KPE

Device Class

Class II

Regulation

21 CFR Part 880.5025

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• External Female Urinary Incontinence

  Class II

  FDA 510(k) K821172 Active Cleared 10 May 1982

• Urinary Collection Container/Leg Bag

  Class II

  FDA 510(k) K821171 Active Cleared 10 May 1982

• Urine Collection Containers, #3600 & 3610

  Class II

  FDA 510(k) K801786 Active Cleared 30 Sep 1980

• Show'rbag

  Class I

  FDA 510(k) K822059 Active Cleared 22 Jul 1982

• Urinary Catheter Care Trays #3700&3710

  Class II

  FDA 510(k) K801787 Active Cleared 21 Oct 1980

• Softic 49

  Class II

  FDA 510(k) K821230 Active Cleared 28 May 1982

See all devices from The Healthcare Group Laboratories, Inc. →

• What is the Empty Solution Transfer Container used for?

  The Empty Solution Transfer Container is designed specifically for the sterile transfer of empty solutions in clinical environments. It is intended to facilitate safe and compatible fluid transfers within intravenous administration systems, ensuring proper handling of solutions before administration to patients.

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

  This device is intended for single-use only. It is packaged in sterile conditions to maintain safety and sterility during clinical procedures, preventing cross-contamination and ensuring compliance with hospital protocols.

• What regulatory approval does the Empty Solution Transfer Container hold?

  The Empty Solution Transfer Container has received FDA 510(k) clearance under the designation K842170. It is classified as a Class II medical device and adheres to regulatory standards for intravenous containers, ensuring its suitability for use in hospital settings.

• How should the Empty Solution Transfer Container be stored?

  The container should be stored in its original sterile packaging until use. It is critical to maintain the integrity of the packaging to preserve sterility. Store in a clean, dry environment away from direct sunlight or extreme temperatures to prevent degradation.

• Does the Empty Solution Transfer Container have any specific compatibility requirements?

  The device is designed to be compatible with standard intravenous administration systems. However, it is essential to verify compatibility with the specific infusion pumps or tubing used in your facility. Always follow manufacturer guidelines and hospital protocols to ensure safe and effective use.