Cleared Traditional

STERILIZATION CASES AND TRAYS (K023658) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K023658 · Carr Metal Products, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Mar 2003
Decision
145d
Days
Class 2
Risk

K023658 is an FDA 510(k) clearance for the STERILIZATION CASES AND TRAYS. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Carr Metal Products, Inc. (Mccordsville, US). The FDA issued a Cleared decision on March 25, 2003 after a review of 145 days - within the typical 510(k) review window.

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. 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.

View all Carr Metal Products, Inc. devices

Submission Details

510(k) Number K023658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2002
Decision Date March 25, 2003
Days to Decision 145 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
16d slower than avg
Panel avg: 129d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 88
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K023658.
VIS-U-ALL II HEAT-SEAL POUCH AND TUBING
K071087 · STERIS Corporation · Oct 2007
AESCULAP STERILCONTAINER SYSTEM
K053389 · Aesculap, Inc. · Feb 2006
REUSABLE STERILCONTAINER FILTER MODEL #JK090
K041623 · Aesculap, Inc. · Dec 2004
MEDLINE STERILIZATION WRAP
K002968 · Medline Industries, Inc. · Jan 2001
G.E. STERILE, PERCUTANEOUS CHOLANGIOGRAPHIC TRAY
K960204 · GE Medical Systems · Feb 1996
G.E. STERILE, STANDARD BIOPSY TRAY
K960141 · GE Medical Systems · Feb 1996