510(k) · Cleared
ClearedMTS300 Multiple Tray Sterilization System
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 Oct 20, 2015 as substantially equivalent to K110898 (Ammed Surgical Equipment, LLC, 2012) after a 91-day review. Its family tree reaches back 1 generation to 2012. 2 later devices descend from it.
- Decided
- Oct 20, 2015
- Review
- 91 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K110898 (2012). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK110898 S.C.O.R.E.S. UnitAmmed Surgical Equipment, LLC · 2012 · Recalled
- This deviceK152014 MTS300 Multiple Tray Sterilization SystemPmbs, LLC · 2015
- Descendant · cites it directly · 1 of its ownK190541 MTS225 and MTS300 Multiple Tray Sterilization SystemsPmbs, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK222328 SteriCUBE® Multiple Tray Sterilization SystemsStericube, LLC · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K110898 | S.C.O.R.E.S. Unit | Ammed Surgical Equipment, LLC | 2012 | 1 |
| 0 (this device) | K152014 | MTS300 Multiple Tray Sterilization System | Pmbs, LLC | 2015 | — |
| +1 | K190541 | MTS225 and MTS300 Multiple Tray Sterilization Systems | Pmbs, LLC | 2019 | — |
| +2 | K222328 | SteriCUBE® Multiple Tray Sterilization Systems | Stericube, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K110898 | S.C.O.R.E.S. UnitSummary page 4…, LLC, S.C.O.R.E.S. Units, Self Contained Device Operating Room Equipment Sterilization Containers cleared via Premarket Notification 510(k) K110898 on July 26, 2012 Device The MTS300 Multiple Tray Sterilization System (also referred to as the Description MTS… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190541 | MTS225 and MTS300 Multiple Tray Sterilization Systems | 2019 | 1 |
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?
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. 2015, 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 MTS300 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 until used. The unit must be used with the MTS300 Transfer Cart, MTS300 filters and integrity locks. The MTS300 System is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270°F and exposure time of 4…
Read the full statement (150 words)
The MTS300 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 until used. The unit must be used with the MTS300 Transfer Cart, MTS300 filters and integrity locks.
The MTS300 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 MTS300 System was tested and validated with rigid instruments containing lumens with an inner diameter of 3.8mm and an overall length of 370mm. Do not use with instruments containing lumens with an inner diameter smaller than 3.8mm and an overall length longer than 370mm.
Use only uncovered, perforated or wire mesh general delivery trays within the MTS300 System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152014 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152014: MTS300 Multiple Tray Sterilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152014
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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