Cleared Traditional

K945873 - HYPEX(TM) JET INJECTOR

K945873 is an FDA 510(k) clearance for HYPEX(TM) JET INJECTOR, manufactured by Equidyne Systems, Inc.. The device is a Class 2 General Hospital device with product code KZE cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K945873 · Equidyne Systems, Inc. · General Hospital
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Aug 1995
Decision
260d
Days
Class 2
Risk

K945873 is an FDA 510(k) clearance for the HYPEX(TM) JET INJECTOR. Classified as Injector, Fluid, Non-electrically Powered (product code KZE), Class II - Special Controls.

Submitted by Equidyne Systems, Inc. (San Clemente, US). The FDA issued a Cleared decision on August 18, 1995 after a review of 260 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5430 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Equidyne Systems, Inc. devices

FDA 510(k) Submission Details - K945873

510(k) Number K945873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1994
Decision Date August 18, 1995
Days to Decision 260 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 129d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KZE Device Classification - Class 2, Special Controls

Product Code KZE Injector, Fluid, Non-electrically Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5430
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KZE Injector, Fluid, Non-electrically Powered

All 12
Devices cleared under the same product code (KZE) and FDA review panel - the closest regulatory comparables to K945873.
VITAJET
K962625 · Vitajet Corp. · Dec 1996
MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM
K962956 · Medi-Ject Corp. · Oct 1996
MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDRUG DELIVERY SYSTEMS 0.0058/0.0068(INCH DIAMETER NOZZLEORIFIC
K960285 · Medi-Ject Corp. · Apr 1996
PRECI-JET 50
K851181 · Ulster Scientific, Inc. · Jun 1985