Cleared Traditional

K202524 - Standard Sterilizable Tray

K202524 is an FDA 510(k) clearance for Standard Sterilizable Tray, manufactured by Implant Direct Sybron Manufacturing, LLC. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K202524 · Implant Direct Sybron Manufacturing, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2021
Decision
149d
Days
Class 2
Risk

K202524 is an FDA 510(k) clearance for the Standard Sterilizable Tray. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Implant Direct Sybron Manufacturing, LLC (Thousand Oaks, US). The FDA issued a Cleared decision on January 28, 2021 after a review of 149 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 Implant Direct Sybron Manufacturing, LLC devices

FDA 510(k) Submission Details - K202524

510(k) Number K202524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2020
Decision Date January 28, 2021
Days to Decision 149 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
20d slower than avg
Panel avg: 129d · This submission: 149d
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 171
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K202524.
Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes
K201533 · Avinent Implant System S.L.U. · Mar 2021
KARL STORZ UDEL Sterilization Trays
K201945 · KARL STORZ Endoscopy-America, Inc. · Feb 2021
BEGO SEMADOS Tr 58350
K201412 · Bego Implant Systems GmbH & Co. KG · Feb 2021
CrossRoads Tray System
K202268 · Crossroads Extremity Systems, LLC · Dec 2020
EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device
K202270 · K1 Medical, LLC · Dec 2020
NUVO Implant System – NUVO Instrument Kit Cases
K202515 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Nov 2020