Cleared Traditional

K920267 - DYONICS ARTHROSCOPIC KIT

K920267 is an FDA 510(k) clearance for DYONICS ARTHROSCOPIC KIT, manufactured by Smith & Nephew Dyonics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LRO cleared through the Traditional 510(k) pathway after a 427-day FDA review.

K920267 · Smith & Nephew Dyonics, Inc. · General & Plastic Surgery device
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Mar 1993
Decision
427d
Days
Class 2
Risk

K920267 is an FDA 510(k) clearance for the DYONICS ARTHROSCOPIC KIT. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Smith & Nephew Dyonics, Inc. (Andover, US). The FDA issued a Cleared decision on March 23, 1993 after a review of 427 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Smith & Nephew Dyonics, Inc. devices

FDA 510(k) Submission Details - K920267

510(k) Number K920267 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received January 21, 1992
Decision Date March 23, 1993
Days to Decision 427 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
312d slower than avg
Panel avg: 115d · This submission: 427d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRO Device Classification - Class 2, Special Controls

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 46
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K920267.
MEDLINES REPEAT PERFORMANCE SURGICAL PACK SYSTEM
K930700 · Medline Industries, Inc. · Jul 1993
MEDSURG O.R. PROCEDURE TRAY
K914037 · Medsurg Industries, Inc. · Jun 1993
PREP SHAVE KIT (NON-STERILE)
K925016 · Customed, Inc. · Apr 1993
MEDSURG LAPAROSCOPY TRAY
K914036 · Medsurg Industries, Inc. · Mar 1992
STERILE DISPOSABLE WET SKIN SCRUB TRAY
K914174 · Medical Device Inspection Co., Inc. · Feb 1992
WOUND CLOSURE KIT
K910365 · Megadyne Medical Products, Inc. · Mar 1991