Cleared Traditional

K070577 - ON THE GO SHARPS

K070577 is an FDA 510(k) clearance for ON THE GO SHARPS, manufactured by Medport, Inc.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K070577 · Medport, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
135d
Days
Class 2
Risk

K070577 is an FDA 510(k) clearance for the ON THE GO SHARPS. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Medport, Inc. (Beverly, US). The FDA issued a Cleared decision on July 13, 2007 after a review of 135 days - within the typical 510(k) review window.

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 - K070577

510(k) Number K070577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2007
Decision Date July 13, 2007
Days to Decision 135 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
6d slower than avg
Panel avg: 129d · This submission: 135d
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 110
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K070577.
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
SEKURIT SHARPS COLLECTION CONTAINER
K063722 · Techen Safety, Inc. · Mar 2007
SHARPS CONTAINER, MODEL 039-413
K063666 · Biodex Medical Systems, Inc. · Jan 2007
FITPACK
K060037 · Asp Plastics Pty , Ltd. · Jul 2006
K070577 · ON THE GO SHARPS
Download PDF FDA Summary Medport, Inc.