Cleared Traditional

K963219 - RETINAL DETACHMENT IMPLANTS

Also marketed or referenced as:
INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES

K963219 is an FDA 510(k) clearance for RETINAL DETACHMENT IMPLANTS, manufactured by Fci Ophthalmics, Inc.. The device is a Class 2 Ophthalmic device with product code HQX cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K963219 · Fci Ophthalmics, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
73d
Days
Class 2
Risk

K963219 is an FDA 510(k) clearance for the RETINAL DETACHMENT IMPLANTS. Classified as Implant, Orbital, Extra-ocular (product code HQX), Class II - Special Controls.

Submitted by Fci Ophthalmics, Inc. (Marshfield Hills, US). The FDA issued a Cleared decision on October 28, 1996 after a review of 73 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 Fci Ophthalmics, Inc. devices

FDA 510(k) Submission Details - K963219

510(k) Number K963219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1996
Decision Date October 28, 1996
Days to Decision 73 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 110d · This submission: 73d
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

Devices cleared under the same product code (HQX) and FDA review panel - the closest regulatory comparables to K963219.
OCU-GUARD AND OCU-GUARD SUPPLE
K983581 · Bio-Vascular, Inc. · Nov 1998
RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES
K980816 · Fci Ophthalmics, Inc. · Sep 1998
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