Cleared Traditional

K060037 - FITPACK

K060037 is an FDA 510(k) clearance for FITPACK, manufactured by Asp Plastics Pty , Ltd.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K060037 · Asp Plastics Pty , Ltd. · General Hospital
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Jul 2006
Decision
200d
Days
Class 2
Risk

K060037 is an FDA 510(k) clearance for the FITPACK. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Asp Plastics Pty , Ltd. (Mission Viejo, US). The FDA issued a Cleared decision on July 25, 2006 after a review of 200 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 - K060037

510(k) Number K060037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2006
Decision Date July 25, 2006
Days to Decision 200 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 129d · This submission: 200d
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 K060037.
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
ULTI GUARD HOME INSULIN SYRINGE CONTAINER
K021983 · Ultimed, Inc. · Sep 2002
STERISHARP 3-GALLON RSDC, MODEL RSDC3G
K020664 · Sterilogic Waste Systems, Inc. · May 2002
DANIELS SHARPSMART REUSABLE SHARPS CONTAINER
K001337 · The Daniels Corp. · Jul 2000
K060037 · FITPACK
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