510(k) · Cleared
ClearedDePuy Synthes Sterilization Container System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on May 9, 2019 as substantially equivalent to K130720 (Synthes (USA) Products, LLC, 2014) after a 294-day review. Its family tree reaches back 4 generations to 1984.
- Decided
- May 9, 2019
- Review
- 294 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K844652 (1984). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK844652 C.a.S.E. ContainerGeneral Medical Co. · 1984
- 3 generations backK983299 Allegiance Genesis Container SystemAllegiance Healthcare Corp. · 2000
- 2 generations backK112535 Genesis Reusable Rigid Container SystemCarefusion 2200, Inc. · 2012
- 1 generation backK130720 Synthes Reusable Sterilization Container SystemSynthes (USA) Products, LLC · 2014
- This deviceK181933 DePuy Synthes Sterilization Container SystemSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K844652 | C.a.S.E. Container | General Medical Co. | 1984 | — |
| −3 | K983299 | Allegiance Genesis Container System | Allegiance Healthcare Corp. | 2000 | — |
| −2 | K112535 | Genesis Reusable Rigid Container System | Carefusion 2200, Inc. | 2012 | — |
| −1 | K130720 | Synthes Reusable Sterilization Container System | Synthes (USA) Products, LLC | 2014 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K130720 | Synthes Reusable Sterilization Container SystemSummary page 7…Regulation Number: 21 CFR 880.6850 Product Code: KCT Predicate Device Synthes Reusable Sterilization Container System (K130720) To support compatibility of the system with DePuy Synthes Joint Reason for Submission… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 5 companies; a new generation was cleared every 11.7 years on median.
- None of the 6 ancestors has a recall.
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. 2019, 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 DePuy Synthes Sterilization Container System is a device intended to be used to enclose other medical devices to be sterilized by healthcare facilities. It allows sterilization of the enclosed medical devices and maintains sterility of the devices until used for a maximum of 180 days.
The containers are suitable for dynamic air removal (pre-vacuum) steam sterilization when used according to the instructions for use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181933 · printed Nov 4, 2026
Cite this page
510(k) Report. “K181933: DePuy Synthes Sterilization Container System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K181933
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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