Cleared Traditional

K935251 - MARTINEZ ORBITAL IMPLANT

K935251 is an FDA 510(k) clearance for MARTINEZ ORBITAL IMPLANT, manufactured by Miguel Martinez M.D.. The device is a Class 2 Ophthalmic device with product code HPZ cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K935251 · Miguel Martinez M.D. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
120d
Days
Class 2
Risk

K935251 is an FDA 510(k) clearance for the MARTINEZ ORBITAL IMPLANT. Classified as Implant, Eye Sphere (product code HPZ), Class II - Special Controls.

Submitted by Miguel Martinez M.D. (Tucson, US). The FDA issued a Cleared decision on March 1, 1994 after a review of 120 days - within the typical 510(k) review window.

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: 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 Miguel Martinez M.D. devices

FDA 510(k) Submission Details - K935251

510(k) Number K935251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1993
Decision Date March 01, 1994
Days to Decision 120 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
10d slower than avg
Panel avg: 110d · This submission: 120d
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 20
Devices cleared under the same product code (HPZ) and FDA review panel - the closest regulatory comparables to K935251.
MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES
K960859 · Porex Technologies Corp. of Georgia · May 1996
MEDPOR OCULAR SCREW & ACCESSORIES
K954939 · Porex Surgical, Inc. · Jan 1996
MEDPOR SURGICAL IMPLANT MATERIAL
K943275 · Porex Surgical, Inc. · Sep 1994
STERILE/SINGLE USE EYE SPHERE IMPLANTS
K921106 · Storz Instrument Co. · Mar 1992