Autoject 2

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

510(k) Number

K013362 ↗

FDA Product Code

KZH

Device Class

Class II

Regulation

21 CFR Part 880.6920

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Autoject 2 Open recall

  Class II

  FDA 510(k) K945660 Active Cleared 11 Aug 1995

• Unifine Pentips

  Class II

  FDA 510(k) K973899 Active Cleared 4 Dec 1997

• Rapport V.T.D.

  Class II

  FDA 510(k) K971443 Active Cleared 26 Sep 1997

• Owen Mumford 3ml Autopen

  Class II

  FDA 510(k) K983974 Active Cleared 21 Dec 1998

• Amielle

  Class II

  FDA 510(k) K983045 Active Cleared 25 Nov 1998

• Autoject Mini

  Class II

  FDA 510(k) K953735 Active Cleared 8 Nov 1995

See all devices from Owen Mumford USA, Inc. →

• What types of medications can the Autoject 2 be used to deliver, and why is it designed for subcutaneous administration?

  The Autoject 2 is specifically designed for subcutaneous medication delivery, meaning it injects medications just beneath the skin’s surface. This is ideal for medications like insulin or other biologics that require precise, shallow injections. Its autoinjector design automates the process to simplify self-administration, reducing user error and anxiety for patients who need frequent subcutaneous doses. The fixed-needle introducer syringe needle ensures accurate placement without manual depth control.

• Is the Autoject 2 reusable, or is it intended for single-use only? How does this affect its sterility and handling?

  The Autoject 2 is intended for single-use only, as explicitly stated in its design. This ensures sterility is maintained throughout its intended use, as it is supplied sterile from the manufacturer. Single-use devices like this eliminate cross-contamination risks and reduce the need for reprocessing, which is critical for patient safety, especially in general hospital settings where hygiene standards are stringent.

• What sizes or configurations are available for the Autoject 2, and how might this impact clinical use?

  The Autoject 2 comes in multiple sizes and configurations, as evidenced by its registration numbers (e.g., 9681821, 9681538, etc.). These variations likely correspond to different needle gauges, medication volumes, or injection depths, allowing clinicians to select the appropriate model based on patient needs, medication viscosity, or anatomical considerations. This flexibility ensures compatibility with a wide range of subcutaneous medications and patient profiles.

• How should the Autoject 2 be stored, and are there any special considerations for maintaining its functionality?

  While the provided data does not specify storage conditions explicitly, as a sterile, single-use medical device, the Autoject 2 should be stored in a clean, dry environment protected from extreme temperatures, moisture, and direct sunlight. Proper storage ensures the device remains intact and functional until use. Clinicians should follow manufacturer guidelines (available in the product documentation) for optimal shelf life and handling, particularly in hospital settings where multiple units may be stocked.

• What is the regulatory pathway for the Autoject 2, and how does this affect its use in clinical settings?

  The Autoject 2 follows the FDA 510(k) clearance pathway, specifically categorized under traditional review and classified as a Class II medical device (K013362). This means it has been deemed substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards. Clinicians can rely on this regulatory clearance to confirm the device’s compliance with U.S. medical device regulations, though they should always refer to the latest labeling or manufacturer instructions for specific use cases.