Cleared Traditional

K251614 - Stainless Steel Surgical Kits (FDA 510(k) Clearance)

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

K251614 · Dentsply Sirona, Inc. · General Hospital
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Feb 2026
Decision
255d
Days
Class 2
Risk

K251614 is an FDA 510(k) clearance for the Stainless Steel Surgical Kits. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on February 6, 2026 after a review of 255 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 Dentsply Sirona, Inc. devices

Submission Details

510(k) Number K251614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2025
Decision Date February 06, 2026
Days to Decision 255 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
127d slower than avg
Panel avg: 128d · This submission: 255d
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 K251614.
PUREVUE™ Quick Connect Cannula System Tray
K253791 · DePuy Mitek, 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
Aesculap Aicon® Series Container System
K242762 · Aesculap, Inc. · May 2025