510(k) · Cleared
ClearedSterilucent Sterilization Container System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilucent, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jan 20, 2015 as substantially equivalent to K112535 (Carefusion 2200, Inc., 2012) after a 169-day review. Its family tree reaches back 3 generations to 1984.
- Decided
- Jan 20, 2015
- Review
- 169 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. No later device cites it as a predicate yet.
- 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 deviceK142109 Sterilucent Sterilization Container SystemSterilucent, Inc. · 2015
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) | K142109 | Sterilucent Sterilization Container System | Sterilucent, Inc. | 2015 | — |
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 |
|---|---|---|---|
| * | K112535 | Genesis Reusable Rigid Container SystemSummary page 8…ries Product Code: KCT (21 CFR 880.6850) Class: II 2. Predicate Device GenesisTM Reusable Rigid Container System (K112535) 3. Device Description The Sterilucent Sterilization Container System is an assortment of rigid, reusable, stackable containers… | 2012 |
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 31 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.
- 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. 2015, 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 Sterilucent 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 is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. This container system is intended to be used in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer Lumen and Non-Lumen Cycles. The sterility maintenance…
Read the full statement (204 words)
The Sterilucent 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 is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. This container system is intended to be used in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer Lumen and Non-Lumen Cycles. The sterility maintenance period has been validated for a period of up to 180 days.
Reusable baskets and accessory items (clips, posts, pins, dividers, brackets, bars and mats) are intended to organize and secure enclosed medical devices during sterilization, transport, and storage of the container.
Consumable accessory items (filter media, data card and tamper evident arrows) provide a range of functions and are indicated as single-use devices. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Data cards are used to record information regarding a specific sterilization process load. Tamper evident arrows provide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains an external process indicator that serves as a visual indication that the system has been exposed to the Sterilucent VHP sterilization process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142109: Sterilucent 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/K142109
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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