Cleared Traditional

K925671 - DISPOSABLE SCLERAL PLUGS

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

K925671 · O.R. Specialties, Inc. · Ophthalmic device
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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

FDA 510(k) Submission Details - K925671

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.

LXP Device Classification - Class 2, Special Controls

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

All 7
Devices cleared under the same product code (LXP) and FDA review panel - the closest regulatory comparables to K925671.
SCLERAL PLUGS, 19 AND 20 GAUGE
K990872 · Ophthalmic Consultants, Inc. · Jul 1999
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