Cleared Traditional

K081821 - D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP)

K081821 is an FDA 510(k) clearance for D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE A..., manufactured by Global Pathogen Solutions, Inc.. 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.

K081821 · Global Pathogen Solutions, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
67d
Days
Class 2
Risk

K081821 is an FDA 510(k) clearance for the D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP). Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Global Pathogen Solutions, Inc. (Camas, US). The FDA issued a Cleared decision on September 2, 2008 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.

View all Global Pathogen Solutions, Inc. devices

FDA 510(k) Submission Details - K081821

510(k) Number K081821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2008
Decision Date September 02, 2008
Days to Decision 67 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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.

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 49
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K081821.
MEDLINE SHARPS CONTAINERS
K143693 · Medline Industries, Inc. · Nov 2015
MEDLINE SHARPS CONTAINER
K132767 · Medline Industries, Inc. · Feb 2014
BD RECYKLEEN SHARPS COLLECTORS
K112774 · Becton, Dickinson and Company · Mar 2012
STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G
K991612 · Sterilogic Waste Systems, Inc. · May 1999
QLICKSMART
K983367 · Handren Assoc. · Nov 1998
DEMOLIZER #47 ONE-GALLON POINT OF GENERATION SHARPS CONTAINER
K982781 · Thermal Waste Technology, Inc. · Sep 1998