510(k) · Cleared
ClearedMTS225 and MTS300 Multiple Tray Sterilization Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pmbs, LLC · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Nov 5, 2019 as substantially equivalent to K152014 (Pmbs, LLC, 2015) after a 246-day review. Its family tree reaches back 2 generations to 2012. 1 later device descends from it.
- Decided
- Nov 5, 2019
- Review
- 246 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K110898 (2012). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK110898 S.C.O.R.E.S. UnitAmmed Surgical Equipment, LLC · 2012 · Recalled
- 1 generation backK152014 MTS300 Multiple Tray Sterilization SystemPmbs, LLC · 2015
- This deviceK190541 MTS225 and MTS300 Multiple Tray Sterilization SystemsPmbs, LLC · 2019
- Descendant · cites it directly · 0 of its ownK222328 SteriCUBE® Multiple Tray Sterilization SystemsStericube, LLC · 2022
Most influential descendants
Showing 1 of 1 · See all- K222328SteriCUBE® Multiple Tray Sterilization SystemsStericube, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K110898 | S.C.O.R.E.S. Unit | Ammed Surgical Equipment, LLC | 2012 | 1 |
| −1 | K152014 | MTS300 Multiple Tray Sterilization System | Pmbs, LLC | 2015 | — |
| 0 (this device) | K190541 | MTS225 and MTS300 Multiple Tray Sterilization Systems | Pmbs, LLC | 2019 | — |
| +1 | K222328 | SteriCUBE® Multiple Tray Sterilization Systems | Stericube, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KCT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KCT device
- #1 K214041 Aesculap AICON Containerscore 18.1 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K152014 | MTS300 Multiple Tray Sterilization SystemSummary page 4…Device MTS225 and MTS300 Multiple Tray Sterilization Systems Predicate MTS300 Multiple Tray Sterilization System (“MTS300 System”) Device K152014 Device The MTS System is comprised of the stainless steel sterilization cabinet and Description adjustable tra… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222328 | SteriCUBE® Multiple Tray Sterilization Systems | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K222328 (Stericube, LLC, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KCT devicesKCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KCT
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KCT
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KCT
17in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KCT
50in 2025
MAUDE reports naming product code KCT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 199 | 0 | 2 |
| 2008 | 6 | 182 | 0 | 8 |
| 2009 | 6 | 89 | 0 | 5 |
| 2010 | 12 | 202 | 1 | 3 |
| 2011 | 6 | 117 | 2 | 3 |
| 2012 | 10 | 236 | 0 | 2 |
| 2013 | 8 | 131 | 1 | 6 |
| 2014 | 11 | 169 | 1 | 5 |
| 2015 | 15 | 151 | 0 | 6 |
| 2016 | 12 | 182 | 3 | 16 |
| 2017 | 10 | 211 | 1 | 3 |
| 2018 | 15 | 192 | 0 | 22 |
| 2019 | 18 | 187 | 0 | 15 |
| 2020 | 14 | 134 | 0 | 66 |
| 2021 | 18 | 185 | 1 | 26 |
| 2022 | 11 | 137 | 17 | 8 |
| 2023 | 10 | 94 | 0 | 30 |
| 2024 | 8 | 106 | 0 | 18 |
| 2025 | 11 | 205 | 0 | 50 |
| 2026 | 9 | 122 | 0 | — |
What is it indicated for?
The MTS System (Multiple Tray Sterilization System) is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days. The unit must be used with the MTS System Transfer Cart, MTS System Filters and MTS System Integrity Locks. The MTS System is intended to be used in prevacuum steam sterilizers with a prevacuum cycle…
Read the full statement (189 words)
The MTS System (Multiple Tray Sterilization System) is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days. The unit must be used with the MTS System Transfer Cart, MTS System Filters and MTS System Integrity Locks.
The MTS System is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270° F and exposure time of 4 minutes. Use no more than 3 trays per shelf or 25 lbs. per tray.
The MTS System was tested and validated with rigid instruments containing lumens with an inner diameter of .7mm and an overall length of 500mm as well as lumens with an inner diameter of 1.0mm and an overall length of 850mm. Do not use with instruments containing lumens with an inner diameter smaller than .7mm and an overall length longer than 500mm or lumens with an inner diameter smaller than 1.0mm and an overall length longer than 850mm.
Use only uncovered, perforated or wire mesh general delivery trays within the MTS System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190541 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190541: MTS225 and MTS300 Multiple Tray Sterilization Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190541
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026