Cleared Traditional

K980065 - C/T MED-SYSTEMS CASSETTE SYSTEM

K980065 is an FDA 510(k) clearance for C/T MED-SYSTEMS CASSETTE SYSTEM, manufactured by C/T Med System, Ltd.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K980065 · C/T Med System, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
124d
Days
Class 2
Risk

K980065 is an FDA 510(k) clearance for the C/T MED-SYSTEMS CASSETTE SYSTEM. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by C/T Med System, Ltd. (Indianapois, US). The FDA issued a Cleared decision on May 11, 1998 after a review of 124 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 C/T Med System, Ltd. devices

FDA 510(k) Submission Details - K980065

510(k) Number K980065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1998
Decision Date May 11, 1998
Days to Decision 124 days
Submission Type Traditional
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
5d faster than avg
Panel avg: 129d · This submission: 124d
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 186
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K980065.
PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE
K042062 · Bard Peripheral Vascular, Inc. · Sep 2004
OLYMPUS STERILIZATION TRAYS
K033222 · Olympus Winter & Ibe GmbH · Aug 2004
CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS
K972719 · Medicel, S.A. DE C.V. · Feb 1999
KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION
K973827 · Kimberly-Clark Corp. · Feb 1998
SAFEPASS STERILIZATION POUCH
K973981 · Adroit Medical Systems, Inc. · Jan 1998
REXAM FRACTURE RESISTANT POUCH
K973440 · Rexam Medical Packaging, Inc. · Oct 1997