# K110898: S.C.O.R.E.S. Unit

- Pathway: 510(k) (Traditional)
- Applicant: Ammed Surgical Equipment, LLC
- Decided: Jul 26, 2012 after 484 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Allegiance Genesis Container System: named in the summary without a submission number

## Most influential descendants
- K153025: Turbett Surgical Container (2016), 3 descendants of its own
- K200240: Turbett Instrument Pod (2020), 2 descendants of its own
- K152014: MTS300 Multiple Tray Sterilization System (2015), 2 descendants of its own
- K202593: Turbett Instrument Pod (2021), 1 descendant of its own
- K190541: MTS225 and MTS300 Multiple Tray Sterilization Systems (2019), 1 descendant of its own

## Recalls of this device
- Jan 13, 2016 · Class II · Z-1266-2016: Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility.

## Indications for use
The SCORES® Sterilization Container 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 SCORES® transfer cart, SCORES® filters, and integrity locks. The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270' and exposure time of 4 minutes. Use no more than 3 trays per shelf or 25 lbs. per tray. The SCORES® Unit 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 SCORES® Sterilization Container.

Source page: https://510kreport.com/device/K110898
Methodology: https://510kreport.com/methodology