Cleared Special

K040707 - PACKAGING TRAY AND COMPONENTS

K040707 is an FDA 510(k) clearance for PACKAGING TRAY AND COMPONENTS, manufactured by Vygon Us, LLC. The device is a Class 2 General Hospital device with product code FRG cleared through the Special 510(k) pathway after a 29-day FDA review.

K040707 · Vygon Us, LLC · General Hospital
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Apr 2004
Decision
29d
Days
Class 2
Risk

K040707 is an FDA 510(k) clearance for the PACKAGING TRAY AND COMPONENTS. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Vygon Us, LLC (Norristown, US). The FDA issued a Cleared decision on April 16, 2004 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Vygon Us, LLC devices

FDA 510(k) Submission Details - K040707

510(k) Number K040707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2004
Decision Date April 16, 2004
Days to Decision 29 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

FRG Device Classification - Class 2, Special Controls

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 - FRG Wrap, Sterilization

All 198
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K040707.
CONMED LINVATEC INSTRUMENT STERILIZATION TRAY
K052992 · Conmed Linvatec · Oct 2006
AESCULAP STERILCONTAINER SYSTEM
K053389 · Aesculap, Inc. · Feb 2006
REUSABLE STERILCONTAINER FILTER MODEL #JK090
K041623 · Aesculap, Inc. · Dec 2004
APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER
K013003 · Advanced Sterilization Products · Aug 2002
GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM
K012931 · Allegiance Healthcare Corp. · Aug 2002
METAPAK MULTI-PURPOSE INSTRUMENT TRAY
K993535 · Riley Medical, Inc. · Dec 2001