# K032813: The Ultra System SP

- Pathway: 510(k) (Traditional)
- Applicant: Promedica, Inc.
- Decided: Feb 13, 2004 after 157 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 ULTRA SYSTEM SPTM is a reusable sterilization container system intended to allow sterilization of enclosed surgical instruments by health care providers in the STERRADTM 50 and 100S Sterilizers and to maintain sterility of the enclosed instruments until they are used. Baskets are used with the container to facilitate placement of the enclosed surgical instruments. The maximum load is 8.35 pounds in the STERRADThI 50 or 16.70 pounds in the STERRADTM 100S. A maximum of 5 lumens may be sterilized in each load.

Source page: https://510kreport.com/device/K032813
Methodology: https://510kreport.com/methodology