510(k) · Cleared
Recalled · Class II · 2013Codman Quad-Lock Sterilization Container System
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 Apr 16, 2012 as substantially equivalent to K092437 (Codman & Shurtleff, Inc., 2010) after a 90-day review. Its family tree reaches back 4 generations to 1987. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 16, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- KCT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K871202 (1987). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK871202 Flashpak Container SystemPerformance Instruments Corp. · 1987
- 3 generations backK022978 Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc. · 2003
- 2 generations backK072563 Miltex Rigid Container SystemsMiltex, Inc. · 2008
- 1 generation backK092437 Codman Sterilization ContainersCodman & Shurtleff, Inc. · 2010
- This deviceK120117 Codman Quad-Lock Sterilization Container SystemCodman & Shurtleff, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK152111 Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871202 | Flashpak Container System | Performance Instruments Corp. | 1987 | — |
| −3 | K022978 | Steritite Container with Flashtite Valve Plate (S) & Meditray Products | Case Medical, Inc. | 2003 | — |
| −2 | K072563 | Miltex Rigid Container Systems | Miltex, Inc. | 2008 | — |
| −1 | K092437 | Codman Sterilization Containers | Codman & Shurtleff, Inc. | 2010 | — |
| 0 (this device) | K120117 | Codman Quad-Lock Sterilization Container System | Codman & Shurtleff, Inc. | 2012 | — |
| +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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K092437 | Codman Sterilization ContainersSummary page 1…ss 11(21 CFR 880.6850) (KCT) Type of 510(k) Submission: Traditional 51 0(k) Basis for Submission: Expand Indications for Use Predicate Device(s): K092437 Codman® Sterilization Container Device Description The CODMAN QUAD-LOCK Sterili… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152111 | Symmetry Surgical Quad-Lock Container System | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 5, 2013 | Class II | Z-0833-2014 | Process control | The Quad-Lock Sterilization Container System may not maintain an effective sterile barrier. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K152111 (Symmetry Surgical, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K092437.
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. 2012, 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 QUAD-LOCK Sterilization Container System is indicated for use by hospitals and by health care facilities to: *organize and protect stainless steel, aluminum, titanium, plastic and silicone 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…
Read the full statement (221 words)
The CODMAN QUAD-LOCK Sterilization Container System is indicated for use by hospitals and
by health care facilities to:
*organize and protect stainless steel, aluminum, titanium, plastic and silicone 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, titanium, plastic and silicone
surgical instruments.
Lumen inner diameter: 3mm or larger
Lumen length: 400mm or less (medium and large size containers)
250mm 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 QUAD-LOCK Sterilization Container,
the recommended maximum combined weight of the single container, lid, basket/tray and
basket/tray contents is 25 lb. (111.3 kg).
Table 1
Sterilization Parameters
Cycle Type: Prevacuum
Temperature: 13200
Exposure Time: 4 minutes
Dry Time: 30 minutes
The Codman® Quad-Lock™ Sterilization Container Systems can be stacked during sterilization
with up to three containers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120117: Codman Quad-Lock 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/K120117
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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