Cleared Traditional

K831193 - SCLERAL PLUG (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K831193 · Medical Instrument Development Laboratories, Inc. · Ophthalmic device
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Jun 1983
Decision
79d
Days
Class 2
Risk

K831193 is an FDA 510(k) clearance for the SCLERAL PLUG. Classified as Plug, Scleral (product code LXP), Class II - Special Controls.

Submitted by Medical Instrument Development Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4155 - 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 Medical Instrument Development Laboratories, Inc. devices

Submission Details

510(k) Number K831193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1983
Decision Date June 30, 1983
Days to Decision 79 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 110d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LXP Plug, Scleral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4155
Definition Intended To Provide Temporary Closure Of A Scleral Incision During An Ophthalmic Procedure.
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.