Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug Delivery Systems 0.0058/0.0068(Inch Diameter Nozzleorific

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K960285 ↗

FDA Product Code

KZE

Device Class

Class II

Regulation

21 CFR Part 880.5430

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Medi-Jector Choice Needle-Free Insulin Delivery System

  Class II

  FDA 510(k) K962956 Active Cleared 7 Oct 1996

• Modification to Medi-Ject Corporation Medi-Jector Choice Needle-Free Insulin Delivery System

  Class II

  FDA 510(k) K991294 Active Cleared 23 Apr 1999

• What types of medications can the Medi-Jector Needle-Free Bio-Tropin Drug Delivery Systems administer, and how does the nozzle size factor into this?

  The Medi-Jector systems are designed for delivering drugs via a high-pressure fluid jet mechanism without needles, specifically targeting applications in general hospital settings. The nozzle orifice diameters of 0.0058 inches and 0.0068 inches are engineered for precise drug deposition, ensuring controlled delivery of medications through the skin. While the exact medications aren’t specified, the nozzle size likely influences the viscosity and volume of the drug solution for optimal jet penetration and efficacy.

• Are these systems reusable, or are they intended for single-use only, and how should they be stored to maintain sterility?

  The Medi-Jector Needle-Free Bio-Tropin Drug Delivery Systems are explicitly supplied as single-use devices, meaning each unit is intended for one administration only. To preserve sterility and functionality, storage must follow the manufacturer’s guidelines, which likely include keeping them in sealed, sterile packaging until use and avoiding contamination or exposure to environmental conditions that could compromise integrity.

• What regulatory pathway was followed for FDA clearance, and how does this classification impact its use in clinical settings?

  The Medi-Jector systems received FDA 510(k) clearance (K960285) under the Traditional Review pathway, determined to be substantially equivalent to existing products. This classification places them in Class II under the FDA’s regulatory framework, requiring compliance with specific controls to ensure safety and effectiveness. Clinically, this means the device is approved for use in general hospital settings as a non-electrically powered injector, adhering to established standards for needle-free drug delivery.

• What are the key differences between the two nozzle sizes (0.0058 inches vs. 0.0068 inches), and how might a clinician choose between them?

  The two nozzle sizes (0.0058 inches and 0.0068 inches) likely cater to different drug formulations or patient needs, such as varying viscosity or required penetration depth. The smaller orifice (0.0058 inches) may be suited for thinner or lower-volume medications, while the larger orifice (0.0068 inches) could accommodate thicker solutions or higher delivery volumes. Clinicians would select based on manufacturer recommendations, drug specifications, and patient-specific factors like skin condition or medication properties.