Cleared Traditional

K883098 - SITE STERILIZATION TRAYS FOR OPHTHALMIC USE

K883098 is an FDA 510(k) clearance for SITE STERILIZATION TRAYS FOR OPHTHALMIC USE, manufactured by Site Microsurgical Systems, Inc.. The device is a Class 1 General & Plastic Surgery device with product code LRP cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K883098 · Site Microsurgical Systems, Inc. · General & Plastic Surgery device
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Aug 1988
Decision
27d
Days
Class 1
Risk

K883098 is an FDA 510(k) clearance for the SITE STERILIZATION TRAYS FOR OPHTHALMIC USE. Classified as Tray, Surgical (product code LRP), Class I - General Controls.

Submitted by Site Microsurgical Systems, Inc. (Horsham, US). The FDA issued a Cleared decision on August 18, 1988 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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.

FDA 510(k) Submission Details - K883098

510(k) Number K883098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1988
Decision Date August 18, 1988
Days to Decision 27 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

LRP Device Classification - Class 1, General Controls

Product Code LRP Tray, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LRP Tray, Surgical

All 21
Devices cleared under the same product code (LRP) and FDA review panel - the closest regulatory comparables to K883098.
PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES
K905462 · Angiosystems, Inc. · Feb 1991
CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS
K903544 · J.J. Skinner, Inc. · Aug 1990
STERILE LACERATION TRAY
K890071 · Mumtaz I. Malik · Jan 1989
STERILE PACK (PROCEDURAL TRAY/KITS)
K882275 · East Texas Lighthouse For the Blind · Jul 1988
KOI(TM) INSTRUMENT TRAYS
K881095 · CooperVision, Inc. · Apr 1988
SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY
K874665 · Precision Dynamics Corp. · Jan 1988
K883098 · SITE STERILIZATION TRAYS FOR OPHTHALMIC USE
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