Cleared Traditional

K073577 - SHARPS TRANSPORT TUBE, MODEL 50035

K073577 is an FDA 510(k) clearance for SHARPS TRANSPORT TUBE, manufactured by Sharps Compliance, Inc.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K073577 · Sharps Compliance, Inc. · General Hospital
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Jun 2008
Decision
186d
Days
Class 2
Risk

K073577 is an FDA 510(k) clearance for the SHARPS TRANSPORT TUBE, MODEL 50035. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Sharps Compliance, Inc. (Brentwood, US). The FDA issued a Cleared decision on June 23, 2008 after a review of 186 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 - K073577

510(k) Number K073577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2007
Decision Date June 23, 2008
Days to Decision 186 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 129d · This submission: 186d
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

Intertek Testing Services
JAY Y KOGOMA

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 104
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K073577.
SHARPS COMPLIANCE CONTAINER
K083129 · Sharps Compliance, Inc. · Dec 2008
GONGDONG DISPOSABLE SHARP CONTAINER
K082042 · Zhejiang Gongdong Medical Plastic Factory · Sep 2008
D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP)
K081821 · Global Pathogen Solutions, Inc. · Sep 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
SHARPS AWAY DISPOSABLE CONTAINER
K072667 · Solutions, Inc. · Oct 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.

K073577 · SHARPS TRANSPORT TUBE, MODEL 50035
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