Sterile Design-Custom Sterile IV Kit

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

510(k) Number

K842351 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Custom Sterile Procedure Kits

  Not classified

  FDA 510(k) K842356 Active Cleared 21 Mar 1985

• Cardio Metric Custom Perfusion Tubing

  Class II

  FDA 510(k) K841959 Active Cleared 19 Oct 1984

• Pan Set

  Class II

  FDA 510(k) K813437 Active Cleared 31 Dec 1981

• Custom Dressing Change Trays

  Class I

  FDA 510(k) K791738 Active Cleared 2 Oct 1979

• Cardio Metrics Cardiotomy Reservoir

  Class II

  FDA 510(k) K841958 Active Cleared 15 Oct 1984

• Graduated Guide Wire Bowl 8

  Class II

  FDA 510(k) K834237 Active Cleared 4 Feb 1984

See all devices from Sterile Design, Inc. →

• What is the Sterile Design Custom Sterile IV Kit used for?

  This IV kit is designed for administering fluids, medications, or nutrients directly into a patient’s vascular system through a needle or catheter inserted into a vein. It is specifically engineered for use in general hospital settings where precise and sterile fluid delivery is essential, helping to minimize the risk of contamination during intravenous procedures.

• Is the Sterile Design Custom Sterile IV Kit sterile and single-use?

  Yes, the kit is supplied in a sterile configuration and is intended for single-use only. This ensures aseptic conditions during use, as reusing the device could compromise sterility and patient safety. Always follow sterile medical device protocols when handling and storing it.

• What type of regulatory clearance does this IV kit have?

  The Sterile Design Custom Sterile IV Kit holds FDA 510(k) clearance under the reference number K842351. It was determined to be *Substantially Equivalent* (SESE) to a legally marketed device, meaning it meets the same performance standards. This classification falls under product code FPA for Set, Administration, Intravascular.

• How should the Sterile Design Custom Sterile IV Kit be stored?

  The kit must be stored according to sterile medical device protocols to maintain its integrity until use. Ensure it remains in its original packaging, protected from moisture, dust, and physical damage. Avoid exposure to extreme temperatures or direct sunlight, as these can compromise sterility and functionality.

• Is this IV kit suitable for use in MRI environments?

  The provided regulatory data does not specify MRI safety for this device. If MRI compatibility is required, additional verification or manufacturer confirmation should be obtained before use in such environments.