Cleared Traditional

K190840 - Medtronic Transportation / Sterilizatio...

K190840 is the FDA 510(k) clearance for Medtronic Transportation / Sterilizatio... by Medtronic Sofamor Danek USA, Inc.. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K190840 · Medtronic Sofamor Danek USA, Inc. · General Hospital
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Oct 2019
Decision
197d
Days
Class 2
Risk

K190840 is an FDA 510(k) clearance for the Medtronic Transportation / Sterilization Cassettes. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on October 15, 2019 after a review of 197 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 Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K190840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2019
Decision Date October 15, 2019
Days to Decision 197 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
68d slower than avg
Panel avg: 129d · This submission: 197d
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 162
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K190840.
Straumann Modular Cassette
K191522 · Institut Straumann AG · Dec 2019
Pivot System Sterilization case
K181845 · Rp Medical, Inc. · Nov 2019
MTS225 and MTS300 Multiple Tray Sterilization Systems
K190541 · Pmbs, LLC · Nov 2019
Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate
K191475 · Nobel Biocare AB · Aug 2019
Aesculap® SterilContainer(TM) S2 System
K182414 · Aesculap, Inc. · Jul 2019
Sonopet iQ Sterilization Tray
K190667 · Paragon Medical · Jun 2019