Cleared Traditional

K923326 - OPHTHALMIC VISCOINJECTOR DRIVE

K923326 is an FDA 510(k) clearance for OPHTHALMIC VISCOINJECTOR DRIVE, manufactured by Synergetics, Inc.. The device is a Class 2 General Hospital device with product code KZE cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K923326 · Synergetics, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
85d
Days
Class 2
Risk

K923326 is an FDA 510(k) clearance for the OPHTHALMIC VISCOINJECTOR DRIVE. Classified as Injector, Fluid, Non-electrically Powered (product code KZE), Class II - Special Controls.

Submitted by Synergetics, Inc. (Chesterfield, US). The FDA issued a Cleared decision on September 30, 1992 after a review of 85 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.

FDA 510(k) Submission Details - K923326

510(k) Number K923326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1992
Decision Date September 30, 1992
Days to Decision 85 days
Submission Type Traditional
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
44d faster than avg
Panel avg: 129d · This submission: 85d
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 44
Devices cleared under the same product code (KZE) and FDA review panel - the closest regulatory comparables to K923326.
HYPEX(TM) JET INJECTOR
K945873 · Equidyne Systems, Inc. · Aug 1995
BIOJECT JET INJECTION SYSTEM
K920631 · Bioject, Inc. · Jun 1994
PRECI-JET 50
K921797 · Hmi Industries, Inc. · Nov 1992
MED-E-JET INJECTOR
K913018 · Med-E-Jet D · Sep 1991
INJECTOR, INSULIN
K905062 · Sound 2000 Medical Systems, Inc. · Mar 1991
VITAJET(INSULIN JET INJECTION DEVICE)
K893215 · Vitajet Industriae Comercioltda. · May 1990
K923326 · OPHTHALMIC VISCOINJECTOR DRIVE
Download PDF FDA Summary Synergetics, Inc.