510(k) · Cleared
ClearedGenesis Reusable Rigid Container System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carefusion 2200, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Apr 27, 2012 as substantially equivalent to K844652 (General Medical Co., 1984) and 2 other predicates after a 239-day review. Its family tree reaches back 2 generations to 1984. 7 later devices descend from it.
- Decided
- Apr 27, 2012
- Review
- 239 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K844652 (1984). 4 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK844652 C.a.S.E. ContainerGeneral Medical Co. · 1984
- 1 generation backK983299 Allegiance Genesis Container SystemAllegiance Healthcare Corp. · 2000
- This deviceK112535 Genesis Reusable Rigid Container SystemCarefusion 2200, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK140850 Genesis Reusable Rigid Container SystemCarefusion 2200, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK142529 Genesis Reusable Rigid Container SystemCarefusion 2200, Inc. · 2015 · Recalled
- Descendant · cites it directly · 1 of its ownK130720 Synthes Reusable Sterilization Container SystemSynthes (USA) Products, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK181933 DePuy Synthes Sterilization Container SystemSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK162600 Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc. · 2016 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K140850Genesis Reusable Rigid Container SystemCarefusion 2200, Inc. · 2014 · cites it directly3descendants
- K142529Genesis Reusable Rigid Container SystemCarefusion 2200, Inc. · 2015 · 2 generations on2descendants
- K130720Synthes Reusable Sterilization Container SystemSynthes (USA) Products, LLC · 2014 · cites it directly1descendant
- K181933DePuy Synthes Sterilization Container SystemSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2019 · 2 generations on0descendants
- K162600Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K844652 | C.a.S.E. Container | General Medical Co. | 1984 | — |
| −1 | K983299 | Allegiance Genesis Container System | Allegiance Healthcare Corp. | 2000 | — |
| 0 (this device) | K112535 | Genesis Reusable Rigid Container System | Carefusion 2200, Inc. | 2012 | — |
| +1 | K140850 | Genesis Reusable Rigid Container System | Carefusion 2200, Inc. | 2014 | — |
| +2 | K142529 | Genesis Reusable Rigid Container System | Carefusion 2200, Inc. | 2015 | 2 |
| +1 | K130720 | Synthes Reusable Sterilization Container System | Synthes (USA) Products, LLC | 2014 | — |
| +2 | K181933 | DePuy Synthes Sterilization Container System | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2019 | — |
| +3 | K162600 | Jewel Precision Reusable Rigid Sterilization Container System | Jewel Precision Sheet Metal & Machine, Inc. | 2016 | 1 |
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 |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K844652 | C.a.S.E. ContainerSummary page 1…es and Other Accessories Classification panel 80. Regulation 880.6850 -Product Code(s) KCT Legally marketed K844652 - Genesis Sterilization Container device(s) to which K983299 - Genesis Deep Lid Sterilization Container equivalence… | 1984 |
| * | K983299 | Allegiance Genesis Container SystemSummary page 1…880.6850 -Product Code(s) KCT Legally marketed K844652 - Genesis Sterilization Container device(s) to which K983299 - Genesis Deep Lid Sterilization Container equivalence is claimed K01 2931 -Genesis STERRAD Sterilization Container Reas… | 2000 |
| * | K012931 | Genesis Sterrad Compatible Reusable Sterilization Container SystemSummary page 1…K844652 - Genesis Sterilization Container device(s) to which K983299 - Genesis Deep Lid Sterilization Container equivalence is claimed K01 2931 -Genesis STERRAD Sterilization Container Reason for 610(k) 0 One filter for all sterilization modalities submis… | 2002 |
What descends from it? (7)
3 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)
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 28 years and passes through 3 companies; a new generation was cleared every 15.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K140850 (Carefusion 2200, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K844652.
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 Genesis Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used for a maximum of 180 days. Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization, immediate use pre-vacuum steam sterilization and 100%…
Read the full statement (187 words)
The Genesis Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used for a maximum of 180 days.
Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization, immediate use pre-vacuum steam sterilization and 100% ethylene oxide sterilization when used as described in the instructions for use.
Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112535: Genesis Reusable Rigid 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/K112535
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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