Cleared Traditional

K972034 - MEDPOR OCULAR CONFORMER

K972034 is an FDA 510(k) clearance for MEDPOR OCULAR CONFORMER, manufactured by Porex Surgical, Inc.. The device is a Class 2 Ophthalmic device with product code HQN cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K972034 · Porex Surgical, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K972034

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.

HQN Device Classification - Class 2, Special Controls

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.