Cleared Traditional

K152014 - MTS300 Multiple Tray Sterilization System

K152014 is the FDA 510(k) clearance for MTS300 Multiple Tray Sterilization System by Pmbs, LLC. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K152014 · Pmbs, LLC · General Hospital
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Oct 2015
Decision
91d
Days
Class 2
Risk

K152014 is an FDA 510(k) clearance for the MTS300 Multiple Tray Sterilization System. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Pmbs, LLC (Stockton, US). The FDA issued a Cleared decision on October 20, 2015 after a review of 91 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 Pmbs, LLC devices

Submission Details

510(k) Number K152014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2015
Decision Date October 20, 2015
Days to Decision 91 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 129d · This submission: 91d
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 K152014.
ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY
K152969 · Conmed Corporation · Mar 2016
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K152241 · Medtronic Sofamor Danek USA, Inc. · Jan 2016
Endoscope Sterilization Tray
K151450 · Intuitive Surgical, Inc. · Jan 2016
SterilContainer S
K151242 · Aesculap, Inc. · Oct 2015
NuVasive Sterilization Trays
K143579 · Nu Vasive, Incorporated · Aug 2015
SterilContainer S
K143729 · Aesculap, Inc. · Aug 2015