510(k) · Cleared
Recalled · Class II · 2025Jewel Precision Reusable Rigid Sterilization Container System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jewel Precision Sheet Metal & Machine, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Dec 9, 2016 as substantially equivalent to K142529 (Carefusion 2200, Inc., 2015) after an 81-day review. Its family tree reaches back 5 generations to 1984. It has been recalled once.
- Decided
- Dec 9, 2016
- Review
- 81 days
- Class
- Class II
- Product code
- KCT
- Recalls
- 1
- 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 deviceK162600 Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, 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) | K162600 | Jewel Precision Reusable Rigid Sterilization Container System | Jewel Precision Sheet Metal & Machine, 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 4…21CFR 880.6850 Product Code(s) KCT Legally Marketed Device to Genesis Reusable Rigid Sterilization Container System which equivalence is claimed K142529 Reason for 51 O(k) submission To obtain clearance to market for a new medical device Device Description The Jewel… | 2015 |
| † | K800123 | Dextex II Sterilization Wrap | 1980 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 22, 2025 | Class II | Z-2026-2025 | No Marketing Application | The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 4 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 Jewel Precision 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 30 days. Jewel Precision Reusable Rigid Sterilization Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization at 270 °F…
Read the full statement (141 words)
The Jewel Precision 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 30 days.
Jewel Precision Reusable Rigid Sterilization Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization at 270 °F (132 °C) for 4 minutes with a drying time of 30 minutes.
Reusable containers, covers, filter holders, insert trays, and accessory items such as brackets of various configuration, dividers, caddies, and silicone nipple mats are intended to organize and secure the enclosed medical devices during sterilization and storage of the container.
Filter media allows ingress and egress of sterilant gas while providing a microbial barrier. Filter media is 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/K162600 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162600: Jewel Precision Reusable Rigid 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/K162600
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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