Cleared Traditional

K102103 - SKELETAL DYNAMICS STERILIZATION TRAYS

K102103 is the FDA 510(k) clearance for SKELETAL DYNAMICS STERILIZATION TRAYS by Skeletal Dynamics, LLC. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K102103 · Skeletal Dynamics, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
133d
Days
Class 2
Risk

K102103 is an FDA 510(k) clearance for the SKELETAL DYNAMICS STERILIZATION TRAYS. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Skeletal Dynamics, LLC (Miami, US). The FDA issued a Cleared decision on December 7, 2010 after a review of 133 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 Skeletal Dynamics, LLC devices

Submission Details

510(k) Number K102103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2010
Decision Date December 07, 2010
Days to Decision 133 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
4d slower than avg
Panel avg: 129d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
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 - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 162
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K102103.
OLYMPUS INSTRUMENT TRAY
K110748 · Olympus Winter & Ibe GmbH · Feb 2012
GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT
K102970 · Gyrus Acmi, Inc. · May 2011
STERILIZATION MATS
K103226 · STERIS Corporation · Feb 2011
SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428
K102122 · Smith & Nephew, Inc. · Nov 2010
VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU
K092745 · STERIS Corporation · Nov 2010
CODMAN STERILIZATION CONTAINERS
K092437 · Codman & Shurtleff, Inc. · Mar 2010