Cleared Traditional

RING SUPPORTED TREPHINE FOR CORNEA TRANS (K843048) - FDA 510(k) Clearance

Class I Ophthalmic device.

K843048 · Precision Instruments, Inc. · Ophthalmic device
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Oct 1984
Decision
63d
Days
Class 1
Risk

K843048 is an FDA 510(k) clearance for the RING SUPPORTED TREPHINE FOR CORNEA TRANS. Classified as Trephine, Manual, Ophthalmic (product code HRH), Class I - General Controls.

Submitted by Precision Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on October 5, 1984 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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 Precision Instruments, Inc. devices

Submission Details

510(k) Number K843048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1984
Decision Date October 05, 1984
Days to Decision 63 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 110d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HRH Trephine, Manual, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
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.