Cleared Traditional

K902308 - TAMCENAN OCULAR EXPLANTS AND BANDS

K902308 is an FDA 510(k) clearance for TAMCENAN OCULAR EXPLANTS AND BANDS, manufactured by Tamcenan Corp.. The device is a Class 2 Ophthalmic device with product code HQX cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K902308 · Tamcenan Corp. · Ophthalmic device
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Jun 1990
Decision
28d
Days
Class 2
Risk

K902308 is an FDA 510(k) clearance for the TAMCENAN OCULAR EXPLANTS AND BANDS. Classified as Implant, Orbital, Extra-ocular (product code HQX), Class II - Special Controls.

Submitted by Tamcenan Corp. (Sioux Falls, US). The FDA issued a Cleared decision on June 19, 1990 after a review of 28 days - a notably fast clearance cycle.

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: 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 Tamcenan Corp. devices

FDA 510(k) Submission Details - K902308

510(k) Number K902308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1990
Decision Date June 19, 1990
Days to Decision 28 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 110d · This submission: 28d
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 K902308.
RETINAL DETACHMENT IMPLANTS
K963219 · Fci Ophthalmics, Inc. · Oct 1996
SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS
K950806 · Mira, Inc. · Jun 1996
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