Dilution Spike

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

510(k) Number

K780209 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Periograf

  Class II

  FDA 510(k) K813070 Active Cleared 20 Nov 1981

• Green Label Biobrane II and Red Label Biobrane II

  Unclassified

  FDA 510(k) K901369 Active Cleared 5 Jun 1990

• Alveograf Durapatite (18-40 Mesh)

  Class II

  FDA 510(k) K813257 Active Cleared 5 Jan 1982

• Periograf Durapatite 40-60 Mesh

  Class II

  FDA 510(k) K840260 Active Cleared 5 Apr 1984

• Empty Sterile Carpuject

  Class II

  FDA 510(k) K820164 Active Cleared 24 Feb 1982

• Biobrane(R) II

  Unclassified

  FDA 510(k) K896110 Active Cleared 28 Nov 1989

See all devices from Sterling Drug, Inc. →

• What is the Dilution Spike used for?

  The Dilution Spike is designed to integrate into intravenous (IV) fluid administration systems, allowing healthcare professionals to precisely dilute medications or fluids directly into IV bags or containers without interrupting the primary fluid flow. This ensures accurate mixing while maintaining compatibility with standard IV tubing and connectors, simplifying the preparation of customized IV solutions in hospital settings.

• Is the Dilution Spike sterile and single-use?

  The Dilution Spike is supplied as a single-use device but is not sterile at the time of shipment. It is intended for use in hospital environments where standard aseptic handling procedures should be followed to maintain sterility during preparation and administration. Always adhere to manufacturer guidelines for proper handling and storage to preserve functionality and sterility prior to use.

• How does the Dilution Spike integrate with existing IV systems?

  The Dilution Spike is engineered to function as a spike adapter, meaning it connects directly to standard IV bags or containers while also accommodating additional tubing for the introduction of diluted medications or fluids. This design ensures seamless integration with existing IV administration systems without requiring modifications to the primary fluid pathway, making it versatile for use in general hospital environments.

• What regulatory clearance does the Dilution Spike hold?

  The Dilution Spike holds FDA 510(k) clearance under the classification of Fluid Management Instruments (FMI), with the clearance number K780209. This clearance was granted in 1978 and confirms its substantial equivalence to a predicate device, allowing it to be marketed for its intended use in IV fluid administration systems. No additional regulatory status beyond this clearance is specified in the submission.

• How should the Dilution Spike be stored before use?

  Prior to use, the Dilution Spike should be stored according to the manufacturer’s guidelines to preserve its functionality and ensure sterility during preparation. Since it is non-sterile at shipment, storage conditions should minimize contamination risks, such as dust or microbial exposure. Always check for any specific storage instructions provided by Sterling Drug, Inc., to maintain the device’s integrity until ready for aseptic handling in clinical settings.