Cleared Traditional

K925671 - DISPOSABLE SCLERAL PLUGS

K925671 is the FDA 510(k) clearance for DISPOSABLE SCLERAL PLUGS by O.R. Specialties, Inc.. It is a Class 2 Ophthalmic device (product code LXP) cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K925671 · O.R. Specialties, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
265d
Days
Class 2
Risk

K925671 is an FDA 510(k) clearance for the DISPOSABLE SCLERAL PLUGS. Classified as Plug, Scleral (product code LXP), Class II - Special Controls.

Submitted by O.R. Specialties, Inc. (Tuscaloosa, US). The FDA issued a Cleared decision on August 2, 1993 after a review of 265 days - an extended review 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: 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 O.R. Specialties, Inc. devices

Submission Details

510(k) Number K925671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1992
Decision Date August 02, 1993
Days to Decision 265 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
155d slower than avg
Panel avg: 110d · This submission: 265d
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.

Regulatory Peers - LXP Plug, Scleral

Devices cleared under the same product code (LXP) and FDA review panel - the closest regulatory comparables to K925671.
VISITEC SCLERAL PLUG
K945114 · Visitec Co. · Feb 1995
PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS
K880952 · Advanced Surgical Products, Inc. · May 1988
ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG
K880953 · Advanced Surgical Products, Inc. · May 1988
MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS
K871604 · Advanced Surgical Products, Inc. · Jun 1987
STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS
K854507 · Storz Instrument Co. · Feb 1986