Cleared Traditional

K860979 - DONALDSON NATURAL EYEPATCH (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K860979 · Keeler Instruments, Inc. · General & Plastic Surgery device
Apr 1986
Decision
21d
Days
Class 1
Risk

K860979 is an FDA 510(k) clearance for the DONALDSON NATURAL EYEPATCH. 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 April 4, 1986 after a review of 21 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K860979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1986
Decision Date April 04, 1986
Days to Decision 21 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 132d · This submission: 21d
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.