510(k) · Cleared
ClearedMiltex Rigid Container Systems
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 Feb 12, 2008 as substantially equivalent to K022978 (Case Medical, Inc., 2003) after a 154-day review. Its family tree reaches back 2 generations to 1987. 7 later devices descend from it.
- Decided
- Feb 12, 2008
- Review
- 154 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K871202 (1987). 5 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK871202 Flashpak Container SystemPerformance Instruments Corp. · 1987
- 1 generation backK022978 Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc. · 2003
- This deviceK072563 Miltex Rigid Container SystemsMiltex, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK102146 Bahadir Sterilization TraysBahadir USA Corp. · 2010 · Recalled
- Descendant · 2 generations on · 2 of its ownK112090 Bahadir Sterilization TraysBahadir USA Corp. · 2012 · Recalled
- Descendant · cites it directly · 2 of its ownK092437 Codman Sterilization ContainersCodman & Shurtleff, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK131407 Bahadir Sterilization TraysBahadir USA Corp. · 2014
- Descendant · 2 generations on · 1 of its ownK120117 Codman Quad-Lock Sterilization Container SystemCodman & Shurtleff, Inc. · 2012 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K102146Bahadir Sterilization TraysBahadir USA Corp. · 2010 · cites it directly3descendants
- K112090Bahadir Sterilization TraysBahadir USA Corp. · 2012 · 2 generations on2descendants
- K092437Codman Sterilization ContainersCodman & Shurtleff, Inc. · 2010 · cites it directly2descendants
- K131407Bahadir Sterilization TraysBahadir USA Corp. · 2014 · 2 generations on1descendant
- K120117Codman Quad-Lock Sterilization Container SystemCodman & Shurtleff, Inc. · 2012 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871202 | Flashpak Container System | Performance Instruments Corp. | 1987 | — |
| −1 | K022978 | Steritite Container with Flashtite Valve Plate (S) & Meditray Products | Case Medical, Inc. | 2003 | — |
| 0 (this device) | K072563 | Miltex Rigid Container Systems | Miltex, Inc. | 2008 | — |
| +1 | K102146 | Bahadir Sterilization Trays | Bahadir USA Corp. | 2010 | 1 |
| +2 | K112090 | Bahadir Sterilization Trays | Bahadir USA Corp. | 2012 | 1 |
| +1 | K092437 | Codman Sterilization Containers | Codman & Shurtleff, Inc. | 2010 | — |
| +2 | K131407 | Bahadir Sterilization Trays | Bahadir USA Corp. | 2014 | — |
| +2 | K120117 | Codman Quad-Lock Sterilization Container System | Codman & Shurtleff, Inc. | 2012 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K022978 | Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsSummary page 1…Class of Device: Class It device, product code KCT Predicate Device: SteriTite® Rigid Sterilization Container System with MediTray Products- Case Medical, Incorporated- K022978 Official Contact: Audie Margrave, Senior Director QA/RA Device Description: The Miltex Rigid Sterilization Container System cons… | 2003 |
What descends from it? (7)
2 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 21 years and passes through 3 companies; a new generation was cleared every 15.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K102146 (Bahadir USA Corp., 2010) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K022978.
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. 2008, 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 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 gravity steam sterilizers. The recommended gravity steam sterilization cycle parameters are 45 minutes exposure at 121 deg C and a 20 minute dry time. 2 metal lumens 3-mm in diameter and up to…
Read the full statement (181 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 gravity steam sterilizers. The recommended gravity steam sterilization cycle parameters are 45 minutes exposure at 121 deg C and a 20 minute dry time. 2 metal lumens 3-mm in diameter and up to 200-mm in length were validated. The container is intended for use with non-porous materials such as stainless steel surgical instruments.
For effective sterilization and drying, the weight of the single container, basket and basket contents should not exceed the following: 16 lbs for the one-half size container, 20 lbs for the three-quarter size container, and 25 lbs for the full size container. Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility for a maximum of 60 days as long as the integrity of the container has not been compromised.
Containers should not be stacked when used within gravity steam sterilizers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072563 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072563: Miltex Rigid Container Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072563
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