Cleared Traditional

K141616 - STERILIZATION CASSETTE

K141616 is an FDA 510(k) clearance for STERILIZATION CASSETTE, manufactured by Oticon Medical AB. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K141616 · Oticon Medical AB · General Hospital
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Sep 2014
Decision
99d
Days
Class 2
Risk

K141616 is an FDA 510(k) clearance for the STERILIZATION CASSETTE. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Oticon Medical AB (Askim, SE). The FDA issued a Cleared decision on September 23, 2014 after a review of 99 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 Oticon Medical AB devices

FDA 510(k) Submission Details - K141616

510(k) Number K141616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2014
Decision Date September 23, 2014
Days to Decision 99 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
30d faster than avg
Panel avg: 129d · This submission: 99d
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 173
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K141616.
SterilContainer S
K143729 · Aesculap, Inc. · Aug 2015
SterilContainer S System
K142970 · Aesculap, Inc. · Jul 2015
Endoscope Sterilization Tray
K142937 · Intuitive Surgical, Inc. · Feb 2015
SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM
K130720 · Synthes USA Products, LLC · Aug 2014
V-PRO STERILIZATION TRAY/ STERILIZATION MAT
K140494 · STERIS Corporation · Jul 2014
VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC
K133116 · Conmed Corporation · Mar 2014