Cleared Traditional

K954939 - MEDPOR OCULAR SCREW & ACCESSORIES

K954939 is an FDA 510(k) clearance for MEDPOR OCULAR SCREW & ACCESSORIES, manufactured by Porex Surgical, Inc.. The device is a Class 2 Ophthalmic device with product code HPZ cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K954939 · Porex Surgical, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
87d
Days
Class 2
Risk

K954939 is an FDA 510(k) clearance for the MEDPOR OCULAR SCREW & ACCESSORIES. Classified as Implant, Eye Sphere (product code HPZ), Class II - Special Controls.

Submitted by Porex Surgical, Inc. (College Park, US). The FDA issued a Cleared decision on January 25, 1996 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3320 - 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 Porex Surgical, Inc. devices

FDA 510(k) Submission Details - K954939

510(k) Number K954939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1995
Decision Date January 25, 1996
Days to Decision 87 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 110d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HPZ Device Classification - Class 2, Special Controls

Product Code HPZ Implant, Eye Sphere
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3320
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 - HPZ Implant, Eye Sphere

All 21
Devices cleared under the same product code (HPZ) and FDA review panel - the closest regulatory comparables to K954939.
EYE SPHERE, CONFORMERS
K972661 · Gulden Ophthalmics · Oct 1997
GORE SPHEREX IMPLANT
K962241 · W.L. Gore & Associates, Inc. · Aug 1996
MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES
K960859 · Porex Technologies Corp. of Georgia · May 1996
MEDPOR SURGICAL IMPLANT MATERIAL
K943275 · Porex Surgical, Inc. · Sep 1994
STERILE/SINGLE USE EYE SPHERE IMPLANTS
K921106 · Storz Instrument Co. · Mar 1992