510(k) · Cleared
ClearedMiltex Rigid Sterilization Container System, (47 Components)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miltex, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Dec 12, 2006 as substantially equivalent to K023614 (Case Medical, Inc., 2003) after a 242-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Dec 12, 2006
- Review
- 242 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K991023 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK991023 Steritite Perforated Bottom Rigid Reusable Sterilization Container…Case Medical, Inc. · 2000
- 2 generations backK012931 Genesis Sterrad Compatible Reusable Sterilization Container SystemAllegiance Healthcare Corp. · 2002
- 1 generation backK023614 Steritite Rigid Reusable Sterilization Container SystemCase Medical, Inc. · 2003 · Recalled
- This deviceK061033 Miltex Rigid Sterilization Container System, (47 Components)Miltex, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991023 | Steritite Perforated Bottom Rigid Reusable Sterilization Container System with… | Case Medical, Inc. | 2000 | — |
| −2 | K012931 | Genesis Sterrad Compatible Reusable Sterilization Container System | Allegiance Healthcare Corp. | 2002 | — |
| −1 | K023614 | Steritite Rigid Reusable Sterilization Container System | Case Medical, Inc. | 2003 | 1 |
| 0 (this device) | K061033 | Miltex Rigid Sterilization Container System, (47 Components) | Miltex, Inc. | 2006 | — |
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 |
|---|---|---|---|
| * | K023614 | Steritite Rigid Reusable Sterilization Container SystemSummary page 1…s 11 device, product code KCT Predicate Device: SteriTite®)Rigid Sterilization Container System with MediTray Products- Case Medical, Incorporated- K0236 14 Official Contact: Charles Weaver, Regulatory Affairs Specialist Device Description: The Miltex… | 2003 |
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 6 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K023614.
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.
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 Miltex Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices, including surfaces and lumens, using ethylene oxide gas sterilizers. Metal lumens 3-mm in diameter and length up to 200-mm in length were validated. The container intended for use with non-porous materials such as stainless steel…
Read the full statement (130 words)
The Miltex Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices, including surfaces and lumens, using ethylene oxide gas sterilizers. Metal lumens 3-mm in diameter and length up to 200-mm in length were validated. The container intended for use with non-porous materials such as stainless steel surgical instruments.
Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility of the medical devices within it until used.
Containers should not be stacked when used within ethylene oxide sterilizers
The device models that are the subject of this pre-market notification on listed on page 2 of this Indications for Use statement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061033 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061033: Miltex Rigid Sterilization Container System, (47 Components).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061033
Report an extraction error
Are you the manufacturer?
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