# K193603: Benesta Medical Sterilization Tray

- Pathway: 510(k) (Traditional)
- Applicant: Caldera Medical, Inc.
- Decided: Jul 20, 2020 after 210 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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

Source page: https://510kreport.com/device/K193603
Methodology: https://510kreport.com/methodology