Cleared Traditional

DTL ELECTRODE (K844409) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844409 · Sauquoit Industries, Inc. · Ophthalmic device
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Feb 1985
Decision
92d
Days
Class 2
Risk

K844409 is an FDA 510(k) clearance for the DTL ELECTRODE. Classified as Electrode, Corneal (product code HLZ), Class II - Special Controls.

Submitted by Sauquoit Industries, Inc. (Scranton, US). The FDA issued a Cleared decision on February 14, 1985 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1220 - 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 Sauquoit Industries, Inc. devices

Submission Details

510(k) Number K844409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1984
Decision Date February 14, 1985
Days to Decision 92 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 110d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HLZ Electrode, Corneal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1220
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 Ophthalmic devices follow this clearance model.