Cleared Abbreviated

K131407 - BAHADIR STERILIZATION TRAYS

K131407 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 Abbreviated 510(k) pathway after a 454-day FDA review.

K131407 · Bahadir USA Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
454d
Days
Class 2
Risk

K131407 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 August 12, 2014 after a review of 454 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

FDA 510(k) Submission Details - K131407

510(k) Number K131407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2013
Decision Date August 12, 2014
Days to Decision 454 days
Submission Type Abbreviated
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
325d slower than avg
Panel avg: 129d · This submission: 454d
Pathway characteristics
Standards-based clearance path.

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 267
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K131407.
STERILIZATION CASSETTE
K141616 · Oticon Medical AB · Sep 2014
GENESIS REUSABLE RIGID CONTAINER SYSTEM
K140850 · Carefusion 2200, Inc. · Aug 2014
SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM
K130720 · Synthes USA Products, LLC · Aug 2014
ENDOSCOPE STERILIZATION TRAY
K133942 · Intuitive Surgical · Aug 2014
V-PRO STERILIZATION TRAY/ STERILIZATION MAT
K140494 · STERIS Corporation · Jul 2014
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
K140289 · Summit Medical, Inc. · Jun 2014
K131407 · BAHADIR STERILIZATION TRAYS
Download PDF FDA Summary Bahadir USA Corp.