Cleared Traditional

K063666 - SHARPS CONTAINER, MODEL 039-413

K063666 is an FDA 510(k) clearance for SHARPS CONTAINER, manufactured by Biodex Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K063666 · Biodex Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
45d
Days
Class 2
Risk

K063666 is an FDA 510(k) clearance for the SHARPS CONTAINER, MODEL 039-413. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Biodex Medical Systems, Inc. (Shirley, US). The FDA issued a Cleared decision on January 25, 2007 after a review of 45 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital 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 - K063666

510(k) Number K063666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2006
Decision Date January 25, 2007
Days to Decision 45 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 129d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMK Device Classification - Class 2, Special Controls

Product Code MMK Container, Sharps
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 Hospital devices follow this clearance model.

Regulatory Peers - MMK Container, Sharps

All 104
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K063666.
SHARPS AWAY DISPOSABLE CONTAINER
K072667 · Solutions, Inc. · Oct 2007
ON THE GO SHARPS
K070577 · Medport, Inc. · Jul 2007
SEKURIT SHARPS COLLECTION CONTAINER
K063722 · Techen Safety, Inc. · Mar 2007
FITPACK
K060037 · Asp Plastics Pty , Ltd. · Jul 2006
ULTI GUARD HOME INSULIN SYRINGE CONTAINER
K021983 · Ultimed, Inc. · Sep 2002
STERISHARP 3-GALLON RSDC, MODEL RSDC3G
K020664 · Sterilogic Waste Systems, Inc. · May 2002
K063666 · SHARPS CONTAINER, MODEL 039-413
Download PDF FDA Summary Biodex Medical System…