Cleared Traditional

K190541 - MTS225 and MTS300 Multiple Tray Sterilization Systems

K190541 is an FDA 510(k) clearance for MTS225 and MTS300 Multiple Tray Sterili..., 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 246-day FDA review.

K190541 · Pmbs, LLC · General Hospital
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Nov 2019
Decision
246d
Days
Class 2
Risk

K190541 is an FDA 510(k) clearance for the MTS225 and MTS300 Multiple Tray Sterilization Systems. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Pmbs, LLC (Gulfport, US). The FDA issued a Cleared decision on November 5, 2019 after a review of 246 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 Pmbs, LLC devices

FDA 510(k) Submission Details - K190541

510(k) Number K190541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2019
Decision Date November 05, 2019
Days to Decision 246 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
117d slower than avg
Panel avg: 129d · This submission: 246d
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 K190541.
Neodent Instrument Kit Cases
K192670 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Dec 2019
Straumann Modular Cassette
K191522 · Institut Straumann AG · Dec 2019
Pivot System Sterilization case
K181845 · Rp Medical, Inc. · Nov 2019
Medtronic Transportation / Sterilization Cassettes
K190840 · Medtronic Sofamor Danek USA, Inc. · Oct 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