Cleared Traditional

K110262 - SHARPS CONTAINER

K110262 is an FDA 510(k) clearance for SHARPS CONTAINER, manufactured by Noble Marketing. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K110262 · Noble Marketing · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
67d
Days
Class 2
Risk

K110262 is an FDA 510(k) clearance for the SHARPS CONTAINER. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Noble Marketing (Carmel, US). The FDA issued a Cleared decision on April 5, 2011 after a review of 67 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 - K110262

510(k) Number K110262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2011
Decision Date April 05, 2011
Days to Decision 67 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
62d faster than avg
Panel avg: 129d · This submission: 67d
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

Regulatory Technology Services, LLC
MARK JOB

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 94
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K110262.
OAK RIDGE PRODUCTS SHARP CONTAINER
K130281 · Oak Ridge Products, LLC · Jun 2013
SHARPS TANK REUSABLE SHARPS CONTAINER
K111085 · Rehrig Pacific Company · Apr 2012
BD RECYKLEEN SHARPS COLLECTORS
K112774 · Becton, Dickinson and Company · Mar 2012
SHARPS CONTAINER
K101567 · Cixi Leinuo Plastic Co., Ltd. · Sep 2010
SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2
K091736 · Daniels Corporation Pty, Inc. · Oct 2009
SHARP CHUTE
K091690 · Heathrow Scientific, LLC · Jul 2009

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.