510(k) Report

510(k) · Cleared

Cleared

Symmetry Surgical Quad-Lock Container System

K152111510(k) TraditionalCleared Apr 14, 2016260-day reviewClass II21 CFR 880.6850

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

  1. Root · 5 generations backK871202 Flashpak Container SystemPerformance Instruments Corp. · 1987
  2. 4 generations backK022978 Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc. · 2003
  3. 3 generations backK072563 Miltex Rigid Container SystemsMiltex, Inc. · 2008
  4. 2 generations backK092437 Codman Sterilization ContainersCodman & Shurtleff, Inc. · 2010
  5. 1 generation backK120117 Codman Quad-Lock Sterilization Container SystemCodman & Shurtleff, Inc. · 2012 · Recalled
  6. This deviceK152111 Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc. · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K871202Flashpak Container SystemPerformance Instruments Corp.1987—
−4K022978Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc.2003—
−3K072563Miltex Rigid Container SystemsMiltex, Inc.2008—
−2K092437Codman Sterilization ContainersCodman & Shurtleff, Inc.2010—
−1K120117Codman Quad-Lock Sterilization Container SystemCodman & Shurtleff, Inc.20121
0 (this device)K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199730
FIG. 1 — Lineage of K152111, 1987–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K214041 Aesculap AICON Containerscore 18.1 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K092437Codman Sterilization Containers
Summary 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…
Codman & Shurtleff, Inc.2010—
*K120117Codman Quad-Lock Sterilization Container System
Summary 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…
Codman & Shurtleff, Inc.20121

Also cleared against K092437: 1 other device →

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 devices

KCT 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

2007: 32008: 62009: 62010: 122011: 62012: 102013: 82014: 112015: 152016: 122017: 102018: 152019: 182020: 142021: 182022: 112023: 102024: 82025: 112026 (partial year): 9
2007high 18 (2019) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KCT

205in 2025

2007: 199 days median2008: 182 days median2009: 89 days median2010: 202 days median2011: 117 days median2012: 236 days median2013: 131 days median2014: 169 days median2015: 151 days median2016: 182 days median2017: 211 days median2018: 192 days median2019: 187 days median2020: 134 days median2021: 185 days median2022: 137 days median2023: 94 days median2024: 106 days median2025: 205 days median2026 (partial year): 122 days median
2007high 236 (2012) · low 89 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KCT

17in 2022

2010: 12011: 22013: 12014: 12016: 32017: 12021: 12022: 17
2007high 17 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KCT

50in 2025

2007: 22008: 82009: 52010: 32011: 32012: 22013: 62014: 52015: 62016: 162017: 32018: 222019: 152020: 662021: 262022: 82023: 302024: 182025: 50
2007high 66 (2020) · low 2 (2007)2025

MAUDE reports naming product code KCT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007319902
2008618208
200968905
20101220213
2011611723
20121023602
2013813116
20141116915
20151515106
201612182316
20171021113
201815192022
201918187015
202014134066
202118185126
202211137178
20231094030
20248106018
202511205050
202691220—

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.

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