Cleared Traditional

K896017 - THE OPHTHIMUS SYSTEM

K896017 is an FDA 510(k) clearance for THE OPHTHIMUS SYSTEM, manufactured by Hightech Vision. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 351-day FDA review.

K896017 · Hightech Vision · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
351d
Days
Class 2
Risk

K896017 is an FDA 510(k) clearance for the THE OPHTHIMUS SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Hightech Vision (North Caldwell, US). The FDA issued a Cleared decision on October 2, 1990 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - the FDA cardiovascular device oversight 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Hightech Vision devices

FDA 510(k) Submission Details - K896017

510(k) Number K896017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1989
Decision Date October 02, 1990
Days to Decision 351 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
226d slower than avg
Panel avg: 125d · This submission: 351d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 385
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K896017.
MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED)
K920295 · Oxford Medilog, Inc. · Aug 1992
NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS
K905248 · Advanced Technology Laboratories, Inc. · Feb 1991
HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST
K905100 · Hewlett-Packard Co. · Jan 1991
Q5000 PC WORKSTATION
K892113 · Quinton, Inc. · May 1989
WORKSTATION PLUS W/LOCAL AREA NETWORK(LAN) OPTION
K880879 · Ppg Industries, Inc. · Jun 1988
EPICARDIA LE/FD
K881770 · Medicomp, Inc. · May 1988