Cleared Traditional

K863946 - POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT

K863946 is an FDA 510(k) clearance for POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT, manufactured by Porex Medical. The device is a Class 2 Ophthalmic device with product code HQX cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K863946 · Porex Medical · Ophthalmic device
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Feb 1987
Decision
140d
Days
Class 2
Risk

K863946 is an FDA 510(k) clearance for the POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT. Classified as Implant, Orbital, Extra-ocular (product code HQX), Class II - Special Controls.

Submitted by Porex Medical (Fairburn, US). The FDA issued a Cleared decision on February 27, 1987 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3340 - 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 Medical devices

FDA 510(k) Submission Details - K863946

510(k) Number K863946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1986
Decision Date February 27, 1987
Days to Decision 140 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 110d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQX Device Classification - Class 2, Special Controls

Product Code HQX Implant, Orbital, Extra-ocular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3340
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.

Regulatory Peers - HQX Implant, Orbital, Extra-ocular

All 7
Devices cleared under the same product code (HQX) and FDA review panel - the closest regulatory comparables to K863946.
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VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS
K945172 · Visitec Co. · Jan 1995
SCLERAL BUCKLING IMPLANTS DIF/TYPES
K832481 · Storz Instrument Co. · Sep 1983
SILASTIC SCLERAL SPONGE II W/CIRCLING BD
K800140 · Dow Corning Corp. Healthcare Industries Materials · Mar 1980