Cleared Traditional

K160574 - K3PRO SURGICAL TRAY

K160574 is an FDA 510(k) clearance for K3PRO SURGICAL TRAY, manufactured by Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K160574 · Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
294d
Days
Class 2
Risk

K160574 is an FDA 510(k) clearance for the K3PRO SURGICAL TRAY. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG (Bingen Am Rhein, DE). The FDA issued a Cleared decision on December 20, 2016 after a review of 294 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 Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG devices

FDA 510(k) Submission Details - K160574

510(k) Number K160574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2016
Decision Date December 20, 2016
Days to Decision 294 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
165d slower than avg
Panel avg: 129d · This submission: 294d
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 Consultant

Argon Medical Corp.
LINDA SAYLOR

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.

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All 244
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