Cleared Traditional

K960285 - MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDRUG DELIVERY SYSTEMS 0.0058/0.0068(INCH DIAMETER NOZZLEORIFIC

K960285 is an FDA 510(k) clearance for MEDI-JECT CORPORATION MEDI-JECTOR NEEDL..., manufactured by Medi-Ject Corp.. The device is a Class 2 General Hospital device with product code KZE cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K960285 · Medi-Ject Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
89d
Days
Class 2
Risk

K960285 is an FDA 510(k) clearance for the MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDRUG DELIVERY SYSTE.... Classified as Injector, Fluid, Non-electrically Powered (product code KZE), Class II - Special Controls.

Submitted by Medi-Ject Corp. (North Plymouth, US). The FDA issued a Cleared decision on April 17, 1996 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medi-Ject Corp. devices

FDA 510(k) Submission Details - K960285

510(k) Number K960285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1996
Decision Date April 17, 1996
Days to Decision 89 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 129d · This submission: 89d
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

Devices cleared under the same product code (KZE) and FDA review panel - the closest regulatory comparables to K960285.
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