Cleared Traditional

K901553 - SURG-K SURGICAL KERATOMETER

K901553 is an FDA 510(k) clearance for SURG-K SURGICAL KERATOMETER, manufactured by The Sanborn Co.. The device is a Class 1 Ophthalmic device with product code HLR cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K901553 · The Sanborn Co. · Ophthalmic device
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Jul 1990
Decision
108d
Days
Class 1
Risk

K901553 is an FDA 510(k) clearance for the SURG-K SURGICAL KERATOMETER. Classified as Keratoscope, Battery-powered (product code HLR), Class I - General Controls.

Submitted by The Sanborn Co. (Santa Clara, US). The FDA issued a Cleared decision on July 20, 1990 after a review of 108 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 The Sanborn Co. devices

FDA 510(k) Submission Details - K901553

510(k) Number K901553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1990
Decision Date July 20, 1990
Days to Decision 108 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 110d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

HLR Device Classification - Class 1, General Controls

Product Code HLR Keratoscope, Battery-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.