510(k) · Cleared
ClearedSynthes Reusable Sterilization Container System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (USA) Products, LLC · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Aug 14, 2014 as substantially equivalent to K112535 (Carefusion 2200, Inc., 2012) after a 514-day review. Its family tree reaches back 3 generations to 1984. 1 later device descends from it.
- Decided
- Aug 14, 2014
- Review
- 514 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K844652 (1984). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK844652 C.a.S.E. ContainerGeneral Medical Co. · 1984
- 2 generations backK983299 Allegiance Genesis Container SystemAllegiance Healthcare Corp. · 2000
- 1 generation backK112535 Genesis Reusable Rigid Container SystemCarefusion 2200, Inc. · 2012
- This deviceK130720 Synthes Reusable Sterilization Container SystemSynthes (USA) Products, LLC · 2014
- Descendant · cites it directly · 0 of its ownK181933 DePuy Synthes Sterilization Container SystemSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K181933DePuy Synthes Sterilization Container SystemSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K844652 | C.a.S.E. Container | General Medical Co. | 1984 | — |
| −2 | K983299 | Allegiance Genesis Container System | Allegiance Healthcare Corp. | 2000 | — |
| −1 | K112535 | Genesis Reusable Rigid Container System | Carefusion 2200, Inc. | 2012 | — |
| 0 (this device) | K130720 | Synthes Reusable Sterilization Container System | Synthes (USA) Products, LLC | 2014 | — |
| +1 | K181933 | DePuy Synthes Sterilization Container System | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K112535 | Genesis Reusable Rigid Container SystemSummary page 10…Device Class Class II Predicate Device Genesis Reusable Rigid Sterilization Container System (K112535) Reason for Submission Introduction of a Synthes sterilization container for use with… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181933 | DePuy Synthes Sterilization Container System | 2019 | 0 |
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.
What does this lineage say?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 11.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K181933 (Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K112535.
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. 2014, 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 Synthes Reusable Sterilization Container System is a device intended to be used to enclose other medical devices to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical devices and maintains sterility of the devices until used for a maximum of 180 days. Synthes containers are suitable for dynamic air removal (pre-vacuum) steam sterilization when used according to the instructions for use. Reusable lifting platforms…
Read the full statement (176 words)
The Synthes Reusable Sterilization Container System is a device intended to be used to enclose
other medical devices to be sterilized by a healthcare provider. It allows sterilization of the
enclosed medical devices and maintains sterility of the devices until used for a maximum of 180
days.
Synthes containers are suitable for dynamic air removal (pre-vacuum) steam sterilization when
used according to the instructions for use.
Reusable lifting platforms are intended to hold enclosed medical devices above the filter areas of a perforated bottom container during sterilization and storage of the container.
Data cards are used to record information regarding a specific sterilization process load. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evident arrows provide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific (pre-vacuum steam) external process indicator that serves as a visual indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130720 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130720: Synthes Reusable Sterilization Container System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130720
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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