Cleared Traditional

Stryker Universal Select Sterilization Tray System (K173615) - FDA 510(k) Clearance

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

K173615 · Paragon Medical · General Hospital
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Apr 2018
Decision
147d
Days
Class 2
Risk

K173615 is an FDA 510(k) clearance for the Stryker Universal Select Sterilization Tray System. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Paragon Medical (Pierceton, US). The FDA issued a Cleared decision on April 18, 2018 after a review of 147 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 Paragon Medical devices

Submission Details

510(k) Number K173615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2017
Decision Date April 18, 2018
Days to Decision 147 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 129d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Third Party Review Group, LLC
DAVE YUNGVIRT

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 140
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K173615.
Straumann BLX Surgical Cassette
K180791 · Institut Straumann AG · Jun 2018
Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories
K173259 · Case Medical, Inc. · Jun 2018
OsteoMed QuickFix Hybrid MMF Sterilization Tray
K173391 · Osteomed, LLC · May 2018
Neodent Instrument Kits
K171713 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Apr 2018
Instrument basket, for EndoEYE
K171692 · Olympus Winter & Ibe GmbH · Apr 2018
PRO-LITE Sterilization Trays
K172755 · STERIS Corporation · Feb 2018

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.