Cleared Traditional

K222640 - Sweden & Martina Surgical Trays (FDA 510(k) Clearance)

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

K222640 · Sweden & Martina S.P.A. · General Hospital
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May 2023
Decision
267d
Days
Class 2
Risk

K222640 is an FDA 510(k) clearance for the Sweden & Martina Surgical Trays. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Sweden & Martina S.P.A. (Due Carrare, IT). The FDA issued a Cleared decision on May 26, 2023 after a review of 267 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 Sweden & Martina S.P.A. devices

Submission Details

510(k) Number K222640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2022
Decision Date May 26, 2023
Days to Decision 267 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 128d · This submission: 267d
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 Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 276
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K222640.
PUREVUE™ Quick Connect Cannula System Tray
K253791 · DePuy Mitek, Inc. · Feb 2026
Stainless Steel Surgical Kits
K251614 · Dentsply Sirona, Inc. · Feb 2026
Sterilization Trays
K251756 · Paragon Implant Mfg., LLC · Nov 2025
Guided DAS Surgical Kit
K243425 · Talladium Espa?a, SL · Jul 2025
Plastic Surgical Kits
K251300 · Dentsply Sirona, Inc. · Jul 2025
PAL Sterilization Case
K243589 · Microaire Surgical Instruments, LLC · Jun 2025