Pharma-Plast Insulin Infusion Set

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

510(k) Number

K884978 ↗

FDA Product Code

LZG

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K852443 Active Cleared 16 Oct 1985

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  FDA 510(k) K852442 Active Cleared 20 Sep 1985

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  FDA 510(k) K852444 Active Cleared 16 Oct 1985

• Nipro Safelet Cath

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  FDA 510(k) K894371 Active Cleared 25 Oct 1989

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  FDA 510(k) K894372 Active Cleared 28 Sep 1989

• Blood Drawing Needle

  Class II

  FDA 510(k) K894374 Active Cleared 28 Sep 1989

See all devices from Pharma-Plast USA, Inc. →

• What types of insulin pump systems is the Pharma-Plast Insulin Infusion Set compatible with, and how do I determine the correct model for my setup?

  The Pharma-Plast Insulin Infusion Set is designed to work with multiple insulin pump systems, as evidenced by its association with numerous model references (e.g., 3009515470, 3007981285, etc.). To ensure compatibility, check the specific model reference listed on the packaging or consult your pump manufacturer’s documentation. The device is classified under Product Code LZG, which covers insulin infusion sets, so it should align with most external insulin pump systems used in hospital settings.

• Is the Pharma-Plast Insulin Infusion Set intended for single-use only, and if so, what are the implications for clinical workflows?

  Yes, the Pharma-Plast Insulin Infusion Set is explicitly labeled as a single-use device. This means each set is sterile and intended for one-time use only, reducing the risk of contamination or infection. Clinically, this requires proper disposal after use and preparation of a new set for subsequent administrations, ensuring patient safety and compliance with sterile procedures in hospital settings.

• How should the Pharma-Plast Insulin Infusion Set be stored before use, and what are the key considerations for maintaining its sterility?

  The device is supplied sterile for immediate clinical application, so it should be stored in its original, unopened packaging until ready for use. The packaging is designed to preserve sterility, so avoid exposing the set to moisture, dust, or direct sunlight. Once opened, the set must be used promptly to maintain sterility, as it is not intended for later reuse or storage outside its original packaging.

• What regulatory pathway was followed for the FDA clearance of the Pharma-Plast Insulin Infusion Set, and what does this mean for its use in clinical settings?

  The Pharma-Plast Insulin Infusion Set received FDA clearance through a Traditional 510(k) pathway, determined to be *substantially equivalent* to a predicate device. This means the FDA reviewed it against an existing, legally marketed device and confirmed it meets the same performance standards. Clinically, this clearance under Product Code LZG (Pump, Infusion, Insulin) and 21 CFR 880.5725 ensures it adheres to safety and effectiveness requirements for hospital use, particularly in general hospital settings.