Cleared Traditional

K910366 - MEGA GENERAL PURPOSE INSTRUMENT KIT

K910366 is an FDA 510(k) clearance for MEGA GENERAL PURPOSE INSTRUMENT KIT, manufactured by Megadyne Medical Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KDD cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K910366 · Megadyne Medical Products, Inc. · General & Plastic Surgery device
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Mar 1991
Decision
58d
Days
Class 1
Risk

K910366 is an FDA 510(k) clearance for the MEGA GENERAL PURPOSE INSTRUMENT KIT. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by Megadyne Medical Products, Inc. (Hauppauge, US). The FDA issued a Cleared decision on March 28, 1991 after a review of 58 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 - K910366

510(k) Number K910366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1991
Decision Date March 28, 1991
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

KDD Device Classification - Class 1, General Controls

Product Code KDD Kit, Surgical Instrument, Disposable
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 - KDD Kit, Surgical Instrument, Disposable

All 61
Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K910366.
SLIP-PRUF-CLINGER
K913049 · Macbrud Corp. Medical Div. · Sep 1991
BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES
K911606 · Baxter Healthcare Corp · Jul 1991
IN-SIGHT SURGICAL INSTRUMENT KITS, DISPOSABLE
K910816 · Insight International, Inc. · Apr 1991
INCISION AND DRAINAGE KIT
K910369 · Megadyne Medical Products, Inc. · Mar 1991
DISPOSABLE PROCEDURAL TRAYS #CK-XXXXX (VARIOUS)
K902441 · Currie Medical Specialties, Inc. · Aug 1990
SKILCRAFT
K880785 · Pennsylvania Association For the Blind · Mar 1988
K910366 · MEGA GENERAL PURPOSE INSTRUMENT KIT
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