Cleared Traditional

TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM (K911734) - FDA 510(k) Clearance

Class I Ophthalmic device.

K911734 · Northland Cataract & Eye Care Clinic · Ophthalmic device
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Nov 1991
Decision
204d
Days
Class 1
Risk

K911734 is an FDA 510(k) clearance for the TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM. Classified as Strip, Schirmer (product code KYD), Class I - General Controls.

Submitted by Northland Cataract & Eye Care Clinic (Kansas City, US). The FDA issued a Cleared decision on November 7, 1991 after a review of 204 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1800 - 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.

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Submission Details

510(k) Number K911734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1991
Decision Date November 07, 1991
Days to Decision 204 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 110d · This submission: 204d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYD Strip, Schirmer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1800
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.