Cleared Traditional

K190541 - MTS225 and MTS300 Multiple Tray Sterili...

K190541 is the FDA 510(k) clearance for MTS225 and MTS300 Multiple Tray Sterili... by Pmbs, LLC. It is a Class 2 General Hospital device (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

Submission Details

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.

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 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 161
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K190541.
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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