Cleared Traditional

K962625 - VITAJET

K962625 is an FDA 510(k) clearance for VITAJET, manufactured by Vitajet Corp.. The device is a Class 2 General Hospital device with product code KZE cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K962625 · Vitajet Corp. · General Hospital
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Dec 1996
Decision
158d
Days
Class 2
Risk

K962625 is an FDA 510(k) clearance for the VITAJET. Classified as Injector, Fluid, Non-electrically Powered (product code KZE), Class II - Special Controls.

Submitted by Vitajet Corp. (Laguna Hills, US). The FDA issued a Cleared decision on December 10, 1996 after a review of 158 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 Vitajet Corp. devices

FDA 510(k) Submission Details - K962625

510(k) Number K962625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1996
Decision Date December 10, 1996
Days to Decision 158 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 129d · This submission: 158d
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 10
Devices cleared under the same product code (KZE) and FDA review panel - the closest regulatory comparables to K962625.
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
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