Cleared Traditional

K843784 - VITAJET JET INSULIN INJECTION DEVICE

K843784 is an FDA 510(k) clearance for VITAJET JET INSULIN INJECTION DEVICE, manufactured by Vitajet Industriae Comercioltda.. The device is a Class 2 General Hospital device with product code KZE cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K843784 · Vitajet Industriae Comercioltda. · General Hospital
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Nov 1984
Decision
37d
Days
Class 2
Risk

K843784 is an FDA 510(k) clearance for the VITAJET JET INSULIN INJECTION DEVICE. Classified as Injector, Fluid, Non-electrically Powered (product code KZE), Class II - Special Controls.

Submitted by Vitajet Industriae Comercioltda. (Rio De Janeiro Brazil, BR). The FDA issued a Cleared decision on November 2, 1984 after a review of 37 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 Vitajet Industriae Comercioltda. devices

FDA 510(k) Submission Details - K843784

510(k) Number K843784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1984
Decision Date November 02, 1984
Days to Decision 37 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 129d · This submission: 37d
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 21
Devices cleared under the same product code (KZE) and FDA review panel - the closest regulatory comparables to K843784.
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