Cleared Traditional

K203572 - Karl Storz Radel Sterilization Trays (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203572 · KARL STORZ Endoscopy-America, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
May 2021
Decision
151d
Days
Class 2
Risk

K203572 is an FDA 510(k) clearance for the Karl Storz Radel 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 May 7, 2021 after a review of 151 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 K203572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2020
Decision Date May 07, 2021
Days to Decision 151 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
23d slower than avg
Panel avg: 128d · This submission: 151d
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 Group, Inc.
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 276
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