Softinject

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

510(k) Number

K991680 ↗

FDA Product Code

KZH

Device Class

Class II

Regulation

21 CFR Part 880.6920

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• What types of injections is the SoftInject designed to assist with, and how does it improve precision compared to manual methods?

  The SoftInject is specifically designed for subcutaneous and intracavernous injections, helping clinicians administer approved pharmaceuticals with greater precision. Its auto-injector mechanism is engineered to facilitate controlled delivery, reducing variability that can occur with manual syringe use. This is particularly useful in settings where accuracy—such as in intracavernous therapy—is critical for patient outcomes.

• Is the SoftInject intended for reuse, or is it meant to be used only once per patient? How does this affect its clinical workflow?

  The SoftInject is explicitly classified as a single-use medical instrument, meaning it should not be reused on multiple patients. This design choice aligns with sterile-use standards for injectors, minimizing infection risks and ensuring consistent performance. Clinicians should dispose of it after a single use and prepare a new device for subsequent patients, which may require additional planning in busy hospital workflows.

• What sizes or models of the SoftInject are available, and how do they relate to the syringes or needles it’s designed to pair with?

  The SoftInject is not described with specific size or model variations in the provided data, but it is classified as an *introducer syringe needle* and intended for use with commercially available syringes and needles. Its compatibility would depend on the manufacturer’s design to accommodate standard syringe sizes (e.g., 1–5 mL) and needle gauges commonly used in subcutaneous or intracavernous procedures. For exact sizing, refer to Androsystems Srl’s technical documentation or contact their support team.

• How should the SoftInject be stored to maintain its sterility and functionality before use?

  As a sterile medical device, the SoftInject must be stored in its original, unopened packaging to preserve sterility and prevent contamination. The packaging should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Once opened, it should be used immediately and not stored for later use, adhering to single-use guidelines to avoid compromising its sterile integrity.

• What regulatory pathway was followed for the SoftInject’s FDA clearance, and how does this classification impact its use in hospitals?

  The SoftInject received FDA clearance through a 510(k) submission (K991680), classified as *Substantially Equivalent* to a predicate device and falling under device class 2. This regulatory route confirms its compliance with U.S. safety and performance standards for introducer syringe needles in general hospital settings. Hospitals can rely on this classification to ensure the device meets established requirements for sterile, single-use injectors, though local policies may still dictate specific protocols for its integration into clinical workflows.