Cleared Traditional

K901002 - O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES

K901002 is an FDA 510(k) clearance for O'DONNELL, manufactured by Oculo Plastik, Inc.. The device is a Class 2 Ophthalmic device with product code HQX cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K901002 · Oculo Plastik, Inc. · Ophthalmic device
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May 1990
Decision
81d
Days
Class 2
Risk

K901002 is an FDA 510(k) clearance for the O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES. Classified as Implant, Orbital, Extra-ocular (product code HQX), Class II - Special Controls.

Submitted by Oculo Plastik, Inc. (Montreal, Quebec Canada, CA). The FDA issued a Cleared decision on May 22, 1990 after a review of 81 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 Oculo Plastik, Inc. devices

FDA 510(k) Submission Details - K901002

510(k) Number K901002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1990
Decision Date May 22, 1990
Days to Decision 81 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 110d · This submission: 81d
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 K901002.
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K800140 · Dow Corning Corp. Healthcare Industries Materials · Mar 1980