Hypex Jet Injector
by Equidyne Systems, Inc. 510(k)
Active
510(k) K945873
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK945873 | Date18 Aug 1995 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- Full name
- Hypex(Tm) Jet Injector
- 510(k) Number
- FDA Product Code
- KZE
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5430
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Hypex Jet Injector is a non-electrically powered fluid injector designed for subcutaneous or intramuscular administration of medications without the use of a traditional hypodermic needle. It operates by propelling liquid medication through the skin via high-pressure jets, reducing patient discomfort and minimizing the risk of needle-related injuries. This device falls under the classification of a fluid injector and is intended for use in general hospital settings as defined by regulatory submissions.
The Hypex Jet Injector is supplied as a single-use device and is regulated under FDA 510(k) clearance (K945873) with a product code of KZE. It is intended for use in clinical environments where sterile administration of medications is required. The device is not MRI-safe, and its operation does not rely on electrical power. Storage and handling must comply with standard sterile medical device protocols to ensure efficacy and patient safety.
Other devices from Equidyne Systems, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Hypex Jet Injector used for?
The Hypex Jet Injector is designed for subcutaneous or intramuscular administration of medications in clinical environments. It uses high-pressure jets to propel liquid medication through the skin, eliminating the need for traditional hypodermic needles. This method reduces patient discomfort and minimizes the risk of needle-related injuries, making it ideal for general hospital use.
Is the Hypex Jet Injector single-use or reusable?
The Hypex Jet Injector is supplied as a single-use device. This ensures sterility and safety for each patient, adhering to standard sterile medical device protocols required for clinical use.
How is the Hypex Jet Injector powered, and is it MRI-safe?
The Hypex Jet Injector operates without electrical power, relying instead on mechanical means to generate high-pressure jets for medication delivery. It is not MRI-safe, so caution must be exercised when using it in or near MRI environments.
What regulatory clearance does the Hypex Jet Injector hold?
The Hypex Jet Injector holds FDA 510(k) clearance under the classification of a non-electrically powered fluid injector (K945873). It is classified under product code KZE and is intended for use in general hospital settings as defined by regulatory submissions.
How should the Hypex Jet Injector be stored?
The Hypex Jet Injector must be stored and handled according to standard sterile medical device protocols to maintain its efficacy and ensure patient safety. Since it is single-use, it should remain in its original packaging until immediately before use, and any unused devices should be discarded properly.