Autoject Mini

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

510(k) Number

K953735 ↗

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

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  FDA 510(k) K971443 Active Cleared 26 Sep 1997

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  FDA 510(k) K983974 Active Cleared 21 Dec 1998

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  FDA 510(k) K983045 Active Cleared 25 Nov 1998

• Unifine

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  FDA 510(k) K983994 Active Cleared 8 Jan 1999

See all devices from Owen Mumford USA, Inc. →

• What is the Autoject Mini designed for?

  The Autoject Mini is a syringe needle introducer designed specifically for automated subcutaneous or intramuscular injections. It reduces the effort required for administering medication by delivering precise doses with minimal user intervention, making it ideal for both clinical and home-use settings.

• Is the Autoject Mini a single-use or reusable device?

  The Autoject Mini is supplied as a single-use disposable device. This design ensures sterility and reduces the risk of cross-contamination, adhering to standard sterile medical device protocols for safe and hygienic use.

• What regulatory approval does the Autoject Mini hold?

  The Autoject Mini holds FDA 510(k) clearance under the classification of Class II medical devices. It was cleared under regulation number 880.6920 with the 510(k) number K953735, and it is intended for use in general hospital environments.

• How should the Autoject Mini be stored?

  The Autoject Mini should be stored following standard sterile medical device protocols. Since it is a single-use disposable device, it should be kept in a clean, dry environment, protected from contamination, and used within the manufacturer’s specified shelf life.

• What are the key features of the Autoject Mini mechanism?

  The Autoject Mini features a compact, automated mechanism that simplifies the injection process for both healthcare professionals and patients. Its design allows for precise medication delivery with minimal user effort, making it suitable for subcutaneous or intramuscular administration in various settings.