Cleared Traditional

K152014 - MTS300 Multiple Tray Sterilization System

K152014 is an FDA 510(k) clearance for MTS300 Multiple Tray Sterilization System, manufactured by Pmbs, LLC. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K152014

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
Combination Product No
PCCP Authorized No
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.

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

Hillring & Associates, Inc.
ANNETTE M. HILLRING

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.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 230
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K152014.
Endoscope Sterilization Tray
K151450 · Intuitive Surgical, Inc. · Jan 2016
Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray
K152951 · Paragon Medical, Inc. · Dec 2015
INSTRUMENT CASSETTE (EFCCL1-F)
K141854 · Osung Mnd Co., Ltd. · Oct 2015
MIS Spine Frame Instrument Case
K151347 · Thompson Surgical Instruments · Oct 2015
SterilContainer S
K151242 · Aesculap, Inc. · Oct 2015
NuVasive Sterilization Trays
K143579 · Nu Vasive, Incorporated · Aug 2015