Cleared Traditional

ASMOTOM AUTOMATED TREPHINE SYSTEM (K013151) - FDA 510(k) Clearance

Class I Ophthalmic device.

K013151 · Bkg Opthalmics USA, Inc. · Ophthalmic device
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Dec 2001
Decision
85d
Days
Class 1
Risk

K013151 is an FDA 510(k) clearance for the ASMOTOM AUTOMATED TREPHINE SYSTEM. Classified as Engine, Trephine, Accessories, Ac-powered (product code HRG), Class I - General Controls.

Submitted by Bkg Opthalmics USA, Inc. (Appollo Beach, US). The FDA issued a Cleared decision on December 14, 2001 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4070 - the FDA ophthalmic 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.

View all Bkg Opthalmics USA, Inc. devices

Submission Details

510(k) Number K013151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2001
Decision Date December 14, 2001
Days to Decision 85 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 110d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HRG Engine, Trephine, Accessories, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4070
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.