Snapper

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

510(k) Number

K913608 ↗

FDA Product Code

KPE

Device Class

Class II

Regulation

21 CFR Part 880.5025

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Empty Solution Transfer Container W/ Detach Leg

  Class II

  FDA 510(k) K923448 Active Cleared 28 Jul 1993

• Transfer-Aid(Tm)

  Class II

  FDA 510(k) K913985 Active Cleared 18 Mar 1992

• Adfuse(Tm)

  Class II

  FDA 510(k) K881590 Active Cleared 23 May 1988

• Adcomp

  Class II

  FDA 510(k) K860610 Active Cleared 8 Jul 1986

• Adcomp 4000 Hp System

  Class II

  FDA 510(k) K874495 Active Cleared 16 Feb 1988

• Statlock

  Class II

  FDA 510(k) K854008 Active Cleared 13 Nov 1985

See all devices from Healthtek, Inc. →

• What is the Snapper designed to deliver in a patient’s bloodstream?

  The Snapper is a sterile, single-use intravenous (I.V.) container specifically designed to hold and administer intravenous fluids, medications, or nutrients directly into a patient’s bloodstream. Its purpose is to ensure safe and controlled delivery of these substances during infusion therapy, minimizing contamination risks due to its disposable, sealed design.

• How is the Snapper supplied, and what does this mean for clinical use?

  The Snapper is supplied as a sterile, single-use container, meaning each unit is intended for one-time use only. This design eliminates the need for cleaning or reprocessing between patients, reducing the risk of cross-contamination and ensuring consistent sterility. Clinicians should only use one container per patient and discard it immediately after use to maintain safety and compliance with sterile procedures.

• Is the Snapper reusable, or is it intended for single-use only?

  The Snapper is explicitly designed for single-use only. Its sterile packaging and disposable nature prevent reuse, as repeated use could compromise sterility and increase infection risks. Healthtek, Inc. emphasizes this in its design to align with best practices for intravenous administration systems, ensuring patient safety and regulatory compliance.

• What storage conditions are required to maintain the Snapper’s sterility?

  To preserve sterility, the Snapper must be stored in its original, unopened packaging until use. The packaging should remain intact and protected from moisture, dust, or physical damage. Avoid exposing the container to extreme temperatures or direct sunlight, as these conditions could compromise its integrity. Always follow manufacturer guidelines for storage to ensure the device remains safe for administration.

• Can the Snapper be used in MRI environments, or does it have any MRI-related restrictions?

  The Snapper is explicitly not MRI-compatible. This means it should not be used in or near MRI machines, as the magnetic fields could potentially affect the container’s structure or materials. Clinicians should verify the patient’s care plan and ensure the Snapper is not required for MRI procedures. If MRI imaging is needed, alternative non-MRI-compatible devices should be used instead.