510(k) · Cleared
Recalled · Class II · 2016S.C.O.R.E.S. Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ammed Surgical Equipment, LLC · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jul 26, 2012 after a 484-day review. The FDA summary names its predicate without a number. 7 later devices descend from it. It has been recalled once.
- Decided
- Jul 26, 2012
- Review
- 484 days
- Class
- Class II
- Product code
- KCT
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK110898 S.C.O.R.E.S. UnitAmmed Surgical Equipment, LLC · 2012
- Descendant · cites it directly · 3 of its ownK153025 Turbett Surgical ContainerTurbett Surgical, LLC · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK200240 Turbett Instrument PodTurbett Surgical, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK152014 MTS300 Multiple Tray Sterilization SystemPmbs, LLC · 2015
- Descendant · 3 generations on · 1 of its ownK202593 Turbett Instrument PodTurbett Surgical, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK190541 MTS225 and MTS300 Multiple Tray Sterilization SystemsPmbs, LLC · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K153025Turbett Surgical ContainerTurbett Surgical, LLC · 2016 · cites it directly3descendants
- K200240Turbett Instrument PodTurbett Surgical, Inc. · 2020 · 2 generations on2descendants
- K152014MTS300 Multiple Tray Sterilization SystemPmbs, LLC · 2015 · cites it directly2descendants
- K202593Turbett Instrument PodTurbett Surgical, Inc. · 2021 · 3 generations on1descendant
- K190541MTS225 and MTS300 Multiple Tray Sterilization SystemsPmbs, LLC · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K110898 | S.C.O.R.E.S. Unit | Ammed Surgical Equipment, LLC | 2012 | — |
| +1 | K153025 | Turbett Surgical Container | Turbett Surgical, LLC | 2016 | 4 |
| +2 | K200240 | Turbett Instrument Pod | Turbett Surgical, Inc. | 2020 | — |
| +1 | K152014 | MTS300 Multiple Tray Sterilization System | Pmbs, LLC | 2015 | — |
| +3 | K202593 | Turbett Instrument Pod | Turbett Surgical, Inc. | 2021 | — |
| +2 | K190541 | MTS225 and MTS300 Multiple Tray Sterilization Systems | Pmbs, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
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 |
|---|---|---|---|
| * | — | Allegiance Genesis Container System Named without a submission number |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 13, 2016 | Class II | Z-1266-2016 | Device Design | Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K153025 (Turbett Surgical, LLC, 2016) has gone furthest, with 3 descendants of its own.
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. 2012, 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 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…
Read the full statement (151 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110898 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110898: S.C.O.R.E.S. Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110898
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026