Cleared Traditional

K162063 - Steri-Cassette and Steri-Cage Steriliza...

K162063 is the FDA 510(k) clearance for Steri-Cassette and Steri-Cage Steriliza... by Sybron Dental Specialties. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K162063 · Sybron Dental Specialties · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
269d
Days
Class 2
Risk

K162063 is an FDA 510(k) clearance for the Steri-Cassette and Steri-Cage Sterilization Packaging System. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Sybron Dental Specialties (Orange, US). The FDA issued a Cleared decision on April 21, 2017 after a review of 269 days - an extended review cycle.

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 Sybron Dental Specialties devices

Submission Details

510(k) Number K162063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2016
Decision Date April 21, 2017
Days to Decision 269 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
140d slower than avg
Panel avg: 129d · This submission: 269d
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 K162063.
Endoscope Sterilization Tray
K170640 · Intuitive Surgical, Inc. · Sep 2017
Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator
K163598 · Advanced Sterilization Products · Jul 2017
SterilContainer S System
K162815 · Aesculap, Inc. · Jul 2017
Medtronic Transportation/Sterilization Cassettes
K163279 · Medtronic Sofamor Danek USA, Inc. · Feb 2017
Sterilization Tray
K160912 · STERIS Corporation · Oct 2016
Signia sterilization tray
K161347 · Covidien · Sep 2016