510(k) · Cleared
ClearedSteriBest® Sterilization Tray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mastel Surgical · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jun 18, 2026 as substantially equivalent to K171520 (Sterizign Precision Technologies, LLC, 2018) after a 265-day review. Its family tree reaches back 2 generations to 2014.
- Decided
- Jun 18, 2026
- Review
- 265 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K133015 (2014). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K171520 | SteriZign Signatur Device Protection SystemSummary page 6…ries Classification: 21 CFR 880.6850 Class: II Product Code: KCT III. Primary Predicate Devices: K171520, SteriZign Signatur Device Protection System IV. Description: The SteriBest® Sterilization Tray System is a reusab… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- None of the 2 ancestors has a recall.
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. 2026, 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?
SteriBest® Sterilization Tray Systems are intended to organize, transport, store, and protect surgical and other medical devices during sterilization and between clinical uses. The trays are designed to allow sterilization of the enclosed medical devices during validated pre-vacuum steam sterilization cycles. The SteriBest® Sterilization Tray Systems are not intended, on their own, to maintain sterility. The trays have perforations to permit sterilant…
Read the full statement (187 words)
SteriBest® Sterilization Tray Systems are intended to organize, transport, store, and protect surgical and other medical devices during sterilization and between clinical uses. The trays are designed to allow sterilization of the enclosed medical devices during validated pre-vacuum steam sterilization cycles.
The SteriBest® Sterilization Tray Systems are not intended, on their own, to maintain sterility. The trays have perforations to permit sterilant penetration and must be used with a legally marketed, sterile barrier to maintain sterility until point of use.
Validated Sterilization Parameters:
Method Pre-Vacuum Steam
Temperature 270 °F (132 °C)
Exposure Time 4 minutes
Dry Time 30 minutes
Maximum Load per Tray (Tray+ Instruments):
Tray Part Number Maximum Load (g)
CP614 1794
CP634 1794
CP778 1794
CP471D1 366
CP471S 1794
CP1038D1 1049
CP1038D2 1794
CP1038S 1794
Validated Lumen Claims (Per Tray):
Validated lumens consisted of stainless steel.
Base and Lids (Tray) count of lumens ID of lumen (mm)
Part Number
CP471D 4 1.0
CP1038D1 5 1.0
CP614 10 1.0
CP634 10 1.0
CP778 10 1.0
CP471S 10 1.0
CP1038D2 10 1.0
CP1038S 10 1.0
length of lumen (mm)
152
152
152
152
152
152
152
152
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253187: SteriBest® Sterilization Tray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253187
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026