Cleared Traditional

K910368 - MEGA LACERATION KIT

K910368 is the FDA 510(k) clearance for MEGA LACERATION KIT by Megadyne Medical Products, Inc.. It is a Class 2 General & Plastic Surgery device (product code LRO) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K910368 · Megadyne Medical Products, Inc. · General & Plastic Surgery device
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Mar 1991
Decision
48d
Days
Class 2
Risk

K910368 is an FDA 510(k) clearance for the MEGA LACERATION KIT. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Megadyne Medical Products, Inc. (Hauppauge, US). The FDA issued a Cleared decision on March 18, 1991 after a review of 48 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 Megadyne Medical Products, Inc. devices

Submission Details

510(k) Number K910368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1991
Decision Date March 18, 1991
Days to Decision 48 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
67d faster than avg
Panel avg: 115d · This submission: 48d
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 27
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K910368.
PREP SHAVE KIT (NON-STERILE)
K925016 · Customed, Inc. · Apr 1993
MEDSURG LAPAROSCOPY TRAY
K914036 · Medsurg Industries, Inc. · Mar 1992
WOUND CLOSURE KIT
K910365 · Megadyne Medical Products, Inc. · Mar 1991
CUSTOMED ARTHROSCOPY PACK
K902887 · Customed, Inc. · Sep 1990
CUSTOMED ORTHOPEDIC II
K902888 · Customed, Inc. · Sep 1990
CUSTOMED HIP PACT
K903336 · Customed, Inc. · Aug 1990