Cleared Traditional

K201945 - KARL STORZ UDEL Sterilization Trays

K201945 is the FDA 510(k) clearance for KARL STORZ UDEL Sterilization Trays by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K201945 · KARL STORZ Endoscopy-America, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2021
Decision
227d
Days
Class 2
Risk

K201945 is an FDA 510(k) clearance for the KARL STORZ UDEL Sterilization Trays. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on February 25, 2021 after a review of 227 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K201945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2020
Decision Date February 25, 2021
Days to Decision 227 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
98d slower than avg
Panel avg: 129d · This submission: 227d
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 Consultant

Toscano Consulting
David Furr

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 161
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K201945.
ST-Z5
K201878 · Z-Systems AG · Mar 2021
Neodent EasyGuide Kit Cases
K203618 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Mar 2021
Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes
K201533 · Avinent Implant System S.L.U. · Mar 2021
BEGO SEMADOS Tr 58350
K201412 · Bego Implant Systems GmbH & Co. KG · Feb 2021
Standard Sterilizable Tray
K202524 · Implant Direct Sybron Manufacturing, LLC · Jan 2021
CrossRoads Tray System
K202268 · Crossroads Extremity Systems, LLC · Dec 2020