Cleared Traditional

ORBSHOT KERATOMETER (K964891) - FDA 510(k) Clearance

Class I Ophthalmic device.

K964891 · Orbtek, Inc. · Ophthalmic device
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Mar 1997
Decision
110d
Days
Class 1
Risk

K964891 is an FDA 510(k) clearance for the ORBSHOT KERATOMETER. Classified as Topographer, Corneal, Ac-powered (product code MMQ), Class I - General Controls.

Submitted by Orbtek, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 26, 1997 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1350 - the FDA ophthalmic 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 Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Orbtek, Inc. devices

Submission Details

510(k) Number K964891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1996
Decision Date March 26, 1997
Days to Decision 110 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 110d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MMQ Topographer, Corneal, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.