Cleared Traditional

K102146 - BAHADIR STERILIZATION TRAYS

K102146 is an FDA 510(k) clearance for BAHADIR STERILIZATION TRAYS, manufactured by Bahadir USA Corp.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K102146 · Bahadir USA Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
111d
Days
Class 2
Risk

K102146 is an FDA 510(k) clearance for the BAHADIR STERILIZATION TRAYS. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Bahadir USA Corp. (Lindenhurst, US). The FDA issued a Cleared decision on November 18, 2010 after a review of 111 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 Bahadir USA Corp. devices

FDA 510(k) Submission Details - K102146

510(k) Number K102146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2010
Decision Date November 18, 2010
Days to Decision 111 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
18d faster than avg
Panel avg: 129d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KCT Device Classification - Class 2, Special Controls

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 177
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K102146.
SKELETAL DYNAMICS STERILIZATION TRAYS
K102103 · Skeletal Dynamics, LLC · Dec 2010
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
MILTEX THOMPSON CASSETTES
K101653 · Miltex, Inc. · Aug 2010
CODMAN STERILIZATION CONTAINERS
K092437 · Codman & Shurtleff, Inc. · Mar 2010
CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM
K092414 · Conmed Corporation · Mar 2010