510(k) · Cleared
ClearedCodman Sterilization Containers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Mar 25, 2010 as substantially equivalent to K072563 (Miltex, Inc., 2008) after a 230-day review. Its family tree reaches back 3 generations to 1987. 2 later devices descend from it.
- Decided
- Mar 25, 2010
- Review
- 230 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K871202 (1987). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK871202 Flashpak Container SystemPerformance Instruments Corp. · 1987
- 2 generations backK022978 Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc. · 2003
- 1 generation backK072563 Miltex Rigid Container SystemsMiltex, Inc. · 2008
- This deviceK092437 Codman Sterilization ContainersCodman & Shurtleff, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK120117 Codman Quad-Lock Sterilization Container SystemCodman & Shurtleff, Inc. · 2012 · Recalled
- Descendant · cites it directly · 0 of its ownK152111 Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871202 | Flashpak Container System | Performance Instruments Corp. | 1987 | — |
| −2 | K022978 | Steritite Container with Flashtite Valve Plate (S) & Meditray Products | Case Medical, Inc. | 2003 | — |
| −1 | K072563 | Miltex Rigid Container Systems | Miltex, Inc. | 2008 | — |
| 0 (this device) | K092437 | Codman Sterilization Containers | Codman & Shurtleff, Inc. | 2010 | — |
| +1 | K120117 | Codman Quad-Lock Sterilization Container System | Codman & Shurtleff, Inc. | 2012 | 1 |
| +1 | K152111 | Symmetry Surgical Quad-Lock Container System | Symmetry Surgical, Inc. | 2016 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K072563 | Miltex Rigid Container SystemsSummary page 1…Class: Class 11per 21 CFR § 580.6850 Sterilization wrap Predicate Device(s): Miltex Rigid Sterilization Container System K072563 Device Description: The Codman Sterile Container System is designed and manufactured on… | 2008 |
What descends from it? (2)
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 23 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K120117 (Codman & Shurtleff, Inc., 2012) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K072563.
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. 2010, 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 CODMAN Sterilization Container System is indicated for use by hospitals and by health care facilities to: organize and protect stainless steel, aluminum, and titanium general surgical instruments that will be sterilized allow sterilization of the contained instruments by prevacuum steam sterilization (validated, parameters shown in Table 1) maintain the sterility of the contents for up to 180 days during storage and transport within the health care…
Read the full statement (232 words)
The CODMAN Sterilization Container System is indicated for use by hospitals and by health care facilities to:
organize and protect stainless steel, aluminum, and titanium general surgical instruments that will be sterilized
allow sterilization of the contained instruments by prevacuum steam sterilization (validated, parameters shown in Table 1)
maintain the sterility of the contents for up to 180 days during storage and transport within the health care facility, as long as the integrity of the container has not been compromised
The system has not been tested for maintenance of sterility after transportation outside the health care facility.
The system is intended for use with stainless steel, aluminum, and titanium general surgical instruments.
The system is intended for use with lumen instruments as follows:
Lumen inner diameter 3 mm or larger
Lumen length 400 mm or less (medium and large size containers)
250 mm or less (small size containers)
Quantity Up to 4 lumen instruments per container
The system is not intended for the sterilization of endoscopes.
For effective sterilization and drying of any size CODMAN Sterilization Container, the recommended maximum combined weight of the single container, lid, basket and basket contents is 25 lb. (11.3 kg). Please refer to Appendix A for a table of validated configurations of lids, bottoms, safety covers, and accessories.
Table 1
Sterilization Parameters
Cycle Type: Prevacuum; Temperature: 132 °C; Exposure Time: 4 minutes; Dry Time: 30 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092437: Codman Sterilization Containers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092437
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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