Cleared Traditional

K072667 - SHARPS AWAY DISPOSABLE CONTAINER

K072667 is an FDA 510(k) clearance for SHARPS AWAY DISPOSABLE CONTAINER, manufactured by Solutions, Inc.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K072667 · Solutions, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
19d
Days
Class 2
Risk

K072667 is an FDA 510(k) clearance for the SHARPS AWAY DISPOSABLE CONTAINER. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Solutions, Inc. (Louisville, US). The FDA issued a Cleared decision on October 10, 2007 after a review of 19 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 - K072667

510(k) Number K072667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2007
Decision Date October 10, 2007
Days to Decision 19 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 129d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
JEFF D RONGERO

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MMK Container, Sharps

All 110
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K072667.
SHARPS TRANSPORT TUBE, MODEL 50035
K073577 · Sharps Compliance, Inc. · Jun 2008
ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER
K081449 · Ultimed, Inc. · Jun 2008
AP MEDICAL SHARPS CONTAINERS 0,6-12 LT.
K071517 · A.B.M. Italia S.P.A · Apr 2008
ON THE GO SHARPS
K070577 · Medport, Inc. · Jul 2007
SEKURIT SHARPS COLLECTION CONTAINER
K063722 · Techen Safety, Inc. · Mar 2007
SHARPS CONTAINER, MODEL 039-413
K063666 · Biodex Medical Systems, Inc. · Jan 2007

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K072667 · SHARPS AWAY DISPOSABLE CONTAINER
Download PDF FDA Summary Solutions, Inc.