Cleared Traditional

K861749 - 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K861749 · Keeler Instruments, Inc. · General & Plastic Surgery device
May 1986
Decision
17d
Days
Class 1
Risk

K861749 is an FDA 510(k) clearance for the 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE. Classified as Loupe, Diagnostic/surgical (product code FSP), Class I - General Controls.

Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on May 23, 1986 after a review of 17 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 K861749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1986
Decision Date May 23, 1986
Days to Decision 17 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 132d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FSP Loupe, Diagnostic/surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.