Cleared Traditional

ALCON SURGICAL PROCEDURE PACKS (K880961) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K880961 · Alcon Laboratories · General & Plastic Surgery device
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Apr 1988
Decision
52d
Days
Class 2
Risk

K880961 is an FDA 510(k) clearance for the ALCON SURGICAL PROCEDURE PACKS. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on April 29, 1988 after a review of 52 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4370 - 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.

View all Alcon Laboratories devices

Submission Details

510(k) Number K880961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1988
Decision Date April 29, 1988
Days to Decision 52 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 115d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRO General Surgery Tray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - LRO General Surgery Tray

All 109
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K880961.
Medline General Surgery Tray
K213481 · Medline Industries, Inc. · May 2022
Medline Cardiovascular Procedure Kit
K212258 · Medline Industries, Inc. · Dec 2021
PRESBYTERIAN LINEN SERVICES SURGICAL PACKS
K970286 · Medline Industries, Inc. · Mar 1997
MEDLINE RADIOLOGY-DIAGNOSTIC KITS
K962826 · Medline Industries, Inc. · Sep 1996
E-Z PREP(R) TRAY WITH HIBICLENS(R)
K935483 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1994
STERILE INSTRUMENT TRAYS/BASIN SETS
K924468 · Baxter Healthcare Corp · Jul 1993