510(k) · Cleared
ClearedSymmetry Surgical Quad-Lock Container System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Symmetry Surgical, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Apr 14, 2016 as substantially equivalent to K092437 (Codman & Shurtleff, Inc., 2010) and 1 other predicate after a 260-day review. Its family tree reaches back 5 generations to 1987.
- Decided
- Apr 14, 2016
- Review
- 260 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K871202 (1987). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK871202 Flashpak Container SystemPerformance Instruments Corp. · 1987
- 4 generations backK022978 Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc. · 2003
- 3 generations backK072563 Miltex Rigid Container SystemsMiltex, Inc. · 2008
- 2 generations backK092437 Codman Sterilization ContainersCodman & Shurtleff, Inc. · 2010
- 1 generation backK120117 Codman Quad-Lock Sterilization Container SystemCodman & Shurtleff, Inc. · 2012 · Recalled
- This deviceK152111 Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K871202 | Flashpak Container System | Performance Instruments Corp. | 1987 | — |
| −4 | K022978 | Steritite Container with Flashtite Valve Plate (S) & Meditray Products | Case Medical, Inc. | 2003 | — |
| −3 | K072563 | Miltex Rigid Container Systems | Miltex, Inc. | 2008 | — |
| −2 | K092437 | Codman Sterilization Containers | Codman & Shurtleff, Inc. | 2010 | — |
| −1 | K120117 | Codman Quad-Lock Sterilization Container System | Codman & Shurtleff, Inc. | 2012 | 1 |
| 0 (this device) | 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 |
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? (2)
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 12…(21 CFR 880.6850) (KCT) Type of 510(k) Submission: Traditional 510(k) Basis for Submission: Expand Indications for Use Predicate Device(s): K092437, K120117 Codman™ Sterilization Container Device Description: The Symmetry Surgical Quad-Lock® Container System provides a means… | 2010 |
| * | K120117 | Codman Quad-Lock Sterilization Container SystemSummary page 12…80.6850) (KCT) Type of 510(k) Submission: Traditional 510(k) Basis for Submission: Expand Indications for Use Predicate Device(s): K092437, K120117 Codman™ Sterilization Container Device Description: The Symmetry Surgical Quad-Lock® Container System provides a means to organi… | 2012 |
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 29 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 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. 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 Symmetry Surgical Quad-Lock® 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, ethylene oxide, and low temperature hydrogen peroxide sterilization cycles (validated modalities and parameters are shown in Table 1) • When…
Read the full statement (273 words)
The Symmetry Surgical Quad-Lock® 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, ethylene oxide, and low temperature hydrogen peroxide sterilization cycles (validated modalities and parameters are shown in Table 1)
• When sterilized by prevacuum steam sterilization, the Quad-Lock® Containers maintain the sterility of the contents for up to 180 days during storage and transport within the healthcare facility, as long as the integrity of the container has not been compromised
• When sterilized by ethylene oxide or low temperature hydrogen peroxide cycle types the Quad-Lock® Containers maintain the sterility of the contents when sterilized by any of the above for up to 30 days during storage and transport within the healthcare 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.
*The use of plastic instruments has only been confirmed for steam sterilization.
For effective sterilization and drying of any size Symmetry Surgical Quad-Lock® Sterilization Container, the recommended maximum combined weight of the single container, lid, basket/tray and basket/tray contents is defined in Table 1. For each cycle type the qualified lumen size is the minimum diameter and maximum length that has been qualified for use are shown in Table 1. Container System Compatibility by Cycle Type details are shown in Table 2.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152111 · printed Nov 3, 2026
Cite this page
510(k) Report. “K152111: Symmetry Surgical Quad-Lock Container System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K152111
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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