Cleared Traditional

MEDPOR OCULAR CONFORMER (K972034) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K972034 · Porex Surgical, Inc. · Ophthalmic device
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Jan 1998
Decision
232d
Days
Class 2
Risk

K972034 is an FDA 510(k) clearance for the MEDPOR OCULAR CONFORMER. Classified as Conformer, Ophthalmic (product code HQN), Class II - Special Controls.

Submitted by Porex Surgical, Inc. (Fairburn, US). The FDA issued a Cleared decision on January 20, 1998 after a review of 232 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3130 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Porex Surgical, Inc. devices

Submission Details

510(k) Number K972034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1997
Decision Date January 20, 1998
Days to Decision 232 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
122d slower than avg
Panel avg: 110d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQN Conformer, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.