Cleared Traditional

K896473 - H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUR

K896473 is an FDA 510(k) clearance for H200 HANNA SUCTION TREPHINE SYSTEM FOR ..., manufactured by Emory University School of Medicine. The device is a Class 1 Ophthalmic device with product code HPN cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K896473 · Emory University School of Medicine · Ophthalmic device
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Feb 1990
Decision
88d
Days
Class 1
Risk

K896473 is an FDA 510(k) clearance for the H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUR. Classified as Magnet, Permanent (product code HPN), Class I - General Controls.

Submitted by Emory University School of Medicine (Atlanta, US). The FDA issued a Cleared decision on February 9, 1990 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4445 - 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 Emory University School of Medicine devices

FDA 510(k) Submission Details - K896473

510(k) Number K896473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1989
Decision Date February 09, 1990
Days to Decision 88 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 110d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

HPN Device Classification - Class 1, General Controls

Product Code HPN Magnet, Permanent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4445
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.