510(k) · Cleared
ClearedBenesta Medical Sterilization Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caldera Medical, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jul 20, 2020 after a 210-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 20, 2020
- Review
- 210 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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. 2020, 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 BenestaTM Sterilization Tray is intended to enclose and protect the Caldera Medical Rod Lens Hysteroscope and accessories during sterilization and storage. The BenestaTMSterilization Tray must be used in conjunction with a sterilization wrap that is cleared by the FDA for the indicated sterilization cycles. STEAM STERILIZATION Temperature: Pre-Vacuum 132 °C; Gravity 132°C Exposure Time: Pre-Vacuum 4 minutes; Gravity 15 minutes Dry Time: Pre-Vacuum 45…
Read the full statement (128 words)
The BenestaTM Sterilization Tray is intended to enclose and protect the Caldera Medical Rod Lens Hysteroscope and accessories during sterilization and storage.
The BenestaTMSterilization Tray must be used in conjunction with a sterilization wrap that is cleared by the FDA for the indicated sterilization cycles.
STEAM STERILIZATION
Temperature: Pre-Vacuum 132 °C; Gravity 132°C
Exposure Time: Pre-Vacuum 4 minutes; Gravity 15 minutes
Dry Time: Pre-Vacuum 45 minutes; Gravity 45 minutes
Device Storage Conditions: Do not double stack, store in a cool dry location after sterilization
Sterility using FDA validated wrap: Sterility is maintained until wrap is opened or otherwise compromised
Validated Device Contents: ≤20 lbs. (1) Caldera Medical Rod Lens Hysteroscope (1) Caldera Medical Removable Outflow Channel (2) Light post adapters, (1) Valve Cap (2) Valve Insert End Cap
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K193603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193603: Benesta Medical Sterilization Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193603
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026