Cleared Traditional

K874411 - DONALDSON NATURAL EYEPATCH 'PATIENT PAK' (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K874411 · Keeler Instruments, Inc. · General & Plastic Surgery device
Jan 1988
Decision
91d
Days
Class 1
Risk

K874411 is an FDA 510(k) clearance for the DONALDSON NATURAL EYEPATCH 'PATIENT PAK'. Classified as Pad, Eye (product code HMP), Class I - General Controls.

Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on January 27, 1988 after a review of 91 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4440 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K874411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1987
Decision Date January 27, 1988
Days to Decision 91 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 132d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HMP Pad, Eye
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4440
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.