510(k) · Cleared
ClearedGenesis Low Temperature 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 Mar 21, 2016 as substantially equivalent to K142529 (Carefusion 2200, Inc., 2015) after a 98-day review. Its family tree reaches back 5 generations to 1984.
- Decided
- Mar 21, 2016
- Review
- 98 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K844652 (1984). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK844652 C.a.S.E. ContainerGeneral Medical Co. · 1984
- 4 generations backK983299 Allegiance Genesis Container SystemAllegiance Healthcare Corp. · 2000
- 3 generations backK112535 Genesis Reusable Rigid Container SystemCarefusion 2200, Inc. · 2012
- 2 generations backK140850 Genesis Reusable Rigid Container SystemCarefusion 2200, Inc. · 2014
- 1 generation backK142529 Genesis Reusable Rigid Container SystemCarefusion 2200, Inc. · 2015 · Recalled
- This deviceK153554 Genesis Low Temperature Reusable Rigid Container SystemCarefusion 2200, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K844652 | C.a.S.E. Container | General Medical Co. | 1984 | — |
| −4 | K983299 | Allegiance Genesis Container System | Allegiance Healthcare Corp. | 2000 | — |
| −3 | K112535 | Genesis Reusable Rigid Container System | Carefusion 2200, Inc. | 2012 | — |
| −2 | K140850 | Genesis Reusable Rigid Container System | Carefusion 2200, Inc. | 2014 | — |
| −1 | K142529 | Genesis Reusable Rigid Container System | Carefusion 2200, Inc. | 2015 | 2 |
| 0 (this device) | K153554 | Genesis Low Temperature Reusable Rigid Container System | Carefusion 2200, Inc. | 2016 | — |
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 |
|---|---|---|---|
| * | K142529 | Genesis Reusable Rigid Container SystemSummary page 12…Class II per 21CFR 880.6850, Product code KCT Product Code KCT III. PREDICATE DEVICE Genesis™ Rigid Reusable Sterilization Container System, K142529 This predicate has not been subject to a design-related recall. No reference devices were used in this submission. IV. DEVICE DES… | 2015 |
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 32 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K142529.
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. 2016, 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(TM) Low Temperature 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 various STERRAD and V-PRO low temperature sterilization modalities when used as described in…
Read the full statement (181 words)
The Genesis(TM) Low Temperature 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 various STERRAD and V-PRO low temperature sterilization modalities 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 as stated in the FDA summary.
https://510kreport.com/device/K153554 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153554: Genesis Low Temperature 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/K153554
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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