Cleared Traditional

K013003 - APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER

K013003 is an FDA 510(k) clearance for APTIMAX INSTRUMENT TRAY, manufactured by Advanced Sterilization Products. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 356-day FDA review.

K013003 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
356d
Days
Class 2
Risk

K013003 is an FDA 510(k) clearance for the APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on August 28, 2002 after a review of 356 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - 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. Elevated predicate reliance profile. 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.

View all Advanced Sterilization Products devices

FDA 510(k) Submission Details - K013003

510(k) Number K013003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2001
Decision Date August 28, 2002
Days to Decision 356 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
227d slower than avg
Panel avg: 129d · This submission: 356d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 226
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K013003.
WAGNER STERISET STERILIZATION CONTAINER
K041096 · Wagner GmbH · Jun 2005
REUSABLE STERILCONTAINER FILTER MODEL #JK090
K041623 · Aesculap, Inc. · Dec 2004
TIDI BRAND STERILIZATION WRAP
K042580 · Banta Healthcare Group, Ltd. · Nov 2004
GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM
K012931 · Allegiance Healthcare Corp. · Aug 2002
METAPAK MULTI-PURPOSE INSTRUMENT TRAY
K993535 · Riley Medical, Inc. · Dec 2001
MEDLINE STERILIZATION WRAP
K002968 · Medline Industries, Inc. · Jan 2001