Cleared Traditional

K903458 - PRECISION OPTICS IMAGE COUPLER

K903458 is the FDA 510(k) clearance for PRECISION OPTICS IMAGE COUPLER by Precise Optics. It is a Class 2 Gastroenterology & Urology device (product code FET) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K903458 · Precise Optics · Gastroenterology & Urology device
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Oct 1990
Decision
79d
Days
Class 2
Risk

K903458 is an FDA 510(k) clearance for the PRECISION OPTICS IMAGE COUPLER. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Precise Optics (Gardner, US). The FDA issued a Cleared decision on October 19, 1990 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 Precise Optics devices

Submission Details

510(k) Number K903458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1990
Decision Date October 19, 1990
Days to Decision 79 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 130d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FET Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FET Endoscopic Video Imaging System/component, Gastroenterology-urology

All 58
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K903458.
FUJINON VIDEO LAPAROSCOPE -- MODIFIED
K932312 · Fujinon, Inc. · Feb 1994
EPM-3300 VIDEO PROCESSOR
K934918 · Pentax Precision Instrument Corp. · Feb 1994
COLOR VIDEO CAMERA
K911485 · United States Endoscopy Group, Inc. · Aug 1991
OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM)
K870680 · Medline Industries, Inc. · Apr 1987
OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS
K853585 · Olympus Corp. · Jan 1986
VIDEO URODYNAMICS SYS 1906B-Y & 1906C-Y
K843198 · Life-Tech Intl., Inc. · Oct 1984