510(k) Report

510(k) · Cleared

Cleared

C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic

K151386510(k) TraditionalCleared Oct 22, 2015149-day reviewClass II21 CFR 878.3300

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

Atrium Medical Corporation · FTL Mesh, Surgical, Polymeric

Cleared on Oct 22, 2015 as substantially equivalent to K050311 (Atrium Medical Corp., 2006) and 5 other predicates after a 149-day review. Its family tree reaches back 2 generations to 2006.

Decided
Oct 22, 2015
Review
149 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K050311 (2006). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2012: 1 other ancestor2011: 1 other ancestor2009: 2 other ancestorsK050311 · Atrium Medical Corporation C-Qur Mesh · Atrium Medical Corp. · 2006 · recalledK100076 · Atrium C-Qur Ovt Mesh · Atrium Medical Corp. · 2010 · recalled200620082010201220142016
Other ancestors, by generation 1 generation back: 4 other ancestors K100076 · Atrium C-Qur Ovt Mesh · Atrium Medical Corp. · 2010 · recalledK050311 · Atrium Medical Corporation C-Qur Mesh · Atrium Medical Corp. · 2006 · recalled0
  1. Root · 2 generations backK050311 Atrium Medical Corporation C-Qur MeshAtrium Medical Corp. · 2006 · Recalled
  2. 1 generation backK100076 Atrium C-Qur Ovt MeshAtrium Medical Corp. · 2010 · Recalled
  3. This deviceK151386 C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX…Atrium Medical Corporation · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K050311Atrium Medical Corporation C-Qur MeshAtrium Medical Corp.20062
−1K100076Atrium C-Qur Ovt MeshAtrium Medical Corp.20101
0 (this device)K151386C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR MosaicAtrium Medical Corporation2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200920
201110
201210
FIG. 1 — Lineage of K151386, 2006–2015Source: 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 FTL? 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 FTL device

  1. #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 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? (6)

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
*K050311Atrium Medical Corporation C-Qur Mesh
Summary page 10
…K151386 page 2 of 2 Predicate Devices: K050311 Atrium C-QUR™ Mesh K082748 Atrium C-QUR™ FX Mesh K090909 Atriu…
Atrium Medical Corp.20062
*K082748Atrium Prolite S Mesh
Summary page 10
…86 page 2 of 2 Predicate Devices: K050311 Atrium C-QUR™ Mesh K082748 Atrium C-QUR™ FX Mesh K090909 Atrium C-QUR V-Patch™ Mesh K100076…
Atrium Medical Corp.2009—
*K090909C-Qur V -Patch Mesh
Summary page 10
…page 2 of 2 Predicate Devices: K050311 Atrium C-QUR™ Mesh K082748 Atrium C-QUR™ FX Mesh K090909 Atrium C-QUR V-Patch™ Mesh K100076 Atrium C-QUR TacShield™ Mesh K1101…
Atrium Medical Corp.20091
*K100076Atrium C-Qur Ovt Mesh
Summary page 10
…Atrium C-QUR™ Mesh K082748 Atrium C-QUR™ FX Mesh K090909 Atrium C-QUR V-Patch™ Mesh K100076 Atrium C-QUR TacShield™ Mesh K110110 Atrium C-QUR CentriFX™ Mesh K121…
Atrium Medical Corp.20101
*K110110Atrium Centrilfx Mesh
Summary page 10
…C-QUR™ FX Mesh K090909 Atrium C-QUR V-Patch™ Mesh K100076 Atrium C-QUR TacShield™ Mesh K110110 Atrium C-QUR CentriFX™ Mesh K121070 Atrium C-QUR Mosaic™ Mesh Device Description: C-QUR™…
Atrium Medical Corporation2011—
*K121070C-Qur RPM Mesh
Summary page 10
…V-Patch™ Mesh K100076 Atrium C-QUR TacShield™ Mesh K110110 Atrium C-QUR CentriFX™ Mesh K121070 Atrium C-QUR Mosaic™ Mesh Device Description: C-QUR™ Mesh is a sterile, knitted polypropylene m…
Atrium Medical Corp.2012—

Also cleared against K050311: 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 9 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
  • 3 of the 6 ancestors have a recall of any class.
  • 1 other device also cites its predicate K050311.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · FTL

6in 2025

2007: 202008: 232009: 152010: 182011: 152012: 122013: 82014: 112015: 122016: 32017: 62018: 122019: 42020: 52021: 22022: 62023: 42024: 22025: 62026 (partial year): 2
2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007: 92 days median2008: 114 days median2009: 97 days median2010: 132 days median2011: 90 days median2012: 213 days median2013: 90 days median2014: 70 days median2015: 121 days median2016: 186 days median2017: 132 days median2018: 105 days median2019: 99 days median2020: 138 days median2022: 195 days median2023: 29 days median2025: 30 days median
2007high 213 (2012) · low 29 (2023)2026

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

Recalls per year · FTL

1in 2020

2007: 22008: 12009: 12010: 122011: 82012: 22013: 12014: 32017: 12018: 12020: 1
2007high 12 (2010) · low 0 (2015)2026

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

Adverse event reports per year · FTL

3,487in 2025

2007: 1,7372008: 1,5692009: 1,9062010: 2,1752011: 3,6082012: 14,7002013: 26,5192014: 2,6832015: 2,5262016: 2,4172017: 3,9472018: 11,8932019: 21,7242020: 18,8192021: 16,2842022: 11,4392023: 8,0252024: 8,5652025: 3,487
2007high 26,519 (2013) · low 1,569 (2008)2025

MAUDE reports naming product code FTL, 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
2007209221,737
20082311411,569
2009159711,906
201018132122,175
2011159083,608
201212213214,700
2013890126,519
2014117032,683
20151212102,526
2016318602,417
2017613213,947
201812105111,893
2019499021,724
20205138118,819
20212—016,284
20226195011,439
202342908,025
20242—08,565
202563003,487
20262—0—

What is it indicated for?

C-QUR Mesh 1s intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material. C-QUR FX Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material. C-QUR V-Patch…

Read the full statement (179 words)

C-QUR Mesh 1s intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.

C-QUR FX Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.

C-QUR V-Patch Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.

C-QUR TacShield Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.

C-QUR CentriFX Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.

C-QUR Mosaic Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K050311

1 other device cites the same predicate.

  • K100076Atrium C-Qur Ovt MeshAtrium Medical Corp. · 20101 recall

More from Atrium Medical Corporation

6 FDA decisions under this applicant name. See the company

  • K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical Corporation · 2024
  • K201305Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain…Atrium Medical Corporation · 20211 Class I recall
  • K151437ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh PlugAtrium Medical Corporation · 20151 recall
  • K130142Flixene Ifg Vascular GraftAtrium Medical Corporation · 2013
  • K110110Atrium Centrilfx MeshAtrium Medical Corporation · 2011

Recent decisions in FTL

The FTL category page

  • K260474Liora Monofilament ScaffoldTELA Bio, Inc. · 2026
  • K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production · 2026
  • K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production · 2025
  • K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc. · 2025
  • K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc. · 2025

https://510kreport.com/device/K151386 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151386: C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151386

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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