Cleared Traditional

K884974 - ACCESSORY TO EYEDROP GUIDE

K884974 is an FDA 510(k) clearance for ACCESSORY TO EYEDROP GUIDE, manufactured by Suredrop, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code JYJ cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K884974 · Suredrop, Inc. · Ear, Nose, Throat device
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Mar 1989
Decision
114d
Days
Class 1
Risk

K884974 is an FDA 510(k) clearance for the ACCESSORY TO 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 March 24, 1989 after a review of 114 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K884974

510(k) Number K884974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1988
Decision Date March 24, 1989
Days to Decision 114 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
25d slower than avg
Panel avg: 89d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

JYJ Device Classification - Class 1, General Controls

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.