Cleared Traditional

K143693 - MEDLINE SHARPS CONTAINERS

K143693 is an FDA 510(k) clearance for MEDLINE SHARPS CONTAINERS, manufactured by Medline Industries, Inc.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K143693 · Medline Industries, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
317d
Days
Class 2
Risk

K143693 is an FDA 510(k) clearance for the MEDLINE SHARPS CONTAINERS. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on November 6, 2015 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K143693

510(k) Number K143693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2014
Decision Date November 06, 2015
Days to Decision 317 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
188d slower than avg
Panel avg: 129d · This submission: 317d
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 99
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K143693.
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K150333 · Medsource International, LLC · May 2015
B TRAVELSAVVY SHARPS CONTAINER
K140285 · Bellegrove Medical Supply, Inc. · Dec 2014
K143693 · MEDLINE SHARPS CONTAINERS
Download PDF FDA Summary Medline Industries, I…