Cleared Special

K991294 - MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM

K991294 is an FDA 510(k) clearance for MODIFICATION TO MEDI-JECT CORPORATION M..., manufactured by Medi-Ject Corp.. The device is a Class 2 General Hospital device with product code KZE cleared through the Special 510(k) pathway after a 8-day FDA review.

K991294 · Medi-Ject Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
8d
Days
Class 2
Risk

K991294 is an FDA 510(k) clearance for the MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN .... Classified as Injector, Fluid, Non-electrically Powered (product code KZE), Class II - Special Controls.

Submitted by Medi-Ject Corp. (Plymouth, US). The FDA issued a Cleared decision on April 23, 1999 after a review of 8 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K991294

510(k) Number K991294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1999
Decision Date April 23, 1999
Days to Decision 8 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 129d · This submission: 8d
Pathway characteristics
Modification to existing cleared device.

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 42
Devices cleared under the same product code (KZE) and FDA review panel - the closest regulatory comparables to K991294.
SEROJET
K003908 · Bioject, Inc. · Mar 2001
INJEX 50 SYSTEM
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CLICKER
K994384 · Bioject, Inc. · Jun 2000
J-TIP NEEDLESS INJECTOR
K980082 · National Medical Products, Inc. · Mar 1998
J-TIP INJECTOR
K973254 · National Medical Products, Inc. · Nov 1997
BIOJECTOR 2000 MODEL 1B02000
K960373 · Bioject, Inc. · Mar 1997
K991294 · MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM
Download PDF FDA Summary Medi-Ject Corp.