Cleared Traditional

SUREDROP EYEDROP GUIDE (K874569) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K874569 · Suredrop, Inc. · Ear, Nose, Throat device
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May 1988
Decision
180d
Days
Class 1
Risk

K874569 is an FDA 510(k) clearance for the SUREDROP EYEDROP GUIDE. Classified as Gauge, Measuring (product code JYJ), Class I - General Controls.

Submitted by Suredrop, Inc. (Tiger, US). The FDA issued a Cleared decision on May 3, 1988 after a review of 180 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Suredrop, Inc. devices

Submission Details

510(k) Number K874569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1987
Decision Date May 03, 1988
Days to Decision 180 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 89d · This submission: 180d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JYJ Gauge, Measuring
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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.