510(k) · Cleared
Recalled · Class II · 2014Composix L/P Mesh with Echo PS Positioning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Dec 16, 2010 as substantially equivalent to K061754 (Davol Inc., Sub. C. R. Bard, Inc., 2006) and 1 other predicate after an 83-day review. Its family tree reaches back 5 generations to 1994. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 16, 2010
- Review
- 83 days
- Class
- Class II
- Product code
- FTL
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 5 generations to K944418 (1994). 24 ancestors in all, the oldest K926010 (1993). 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK944418 The Spacemaker and the Spacemaker IIGeneral Surgical Innovations · 1994
- 4 generations backK962702 Spacemaker Serial Surgical Balloon Dissector, with Cannula, with…General Surgical Innovations · 1997
- 3 generations backK973046 Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical…General Surgical Innovations · 1998
- 2 generations backK090631 Pajunk Disposable Balloons and Balloon SystemsPAJUNK GmbH Medizintechnologie · 2009
- 1 generation backK092726 Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010
- This deviceK102766 Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010
- Descendant · cites it directly · 5 of its ownK110820 Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK122436 Composix L/P Mesh with Echo PS Positioning System Ventralight ST…C.R. Bard, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 3 of its ownK130968 Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 2 of its ownK143743 ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHC.R. Bard, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK170294 VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”)…C. R. Bard · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011 · cites it directly5descendants
- K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS…C.R. Bard, Inc. · 2012 · cites it directly4descendants
- K130968Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2013 · 2 generations on3descendants
- K143743ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHC.R. Bard, Inc. · 2015 · 2 generations on2descendants
- K170294VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST…C. R. Bard · 2017 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944418 | The Spacemaker and the Spacemaker II | General Surgical Innovations | 1994 | — |
| −4 | K962702 | Spacemaker Serial Surgical Balloon Dissector, with Cannula, with Visualization… | General Surgical Innovations | 1997 | — |
| −3 | K973046 | Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon… | General Surgical Innovations | 1998 | — |
| −2 | K090631 | Pajunk Disposable Balloons and Balloon Systems | PAJUNK GmbH Medizintechnologie | 2009 | — |
| −1 | K092726 | Mesh GPS - Large, Small, SM, SM Small | Surgical Structures, Ltd. | 2010 | — |
| 0 (this device) | K102766 | Composix L/P Mesh with Echo PS Positioning System | C.R. Bard, Inc. | 2010 | — |
| +1 | K110820 | Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System | C.R. Bard, Inc. | 2011 | — |
| +1 | K122436 | Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with… | C.R. Bard, Inc. | 2012 | 15 |
| +2 | K130968 | Ventralight ST Mesh with Echo PS Positioning System | C.R. Bard, Inc. | 2013 | 4 |
| +2 | K143743 | ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH | C.R. Bard, Inc. | 2015 | — |
| +3 | K170294 | VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle… | C. R. Bard | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 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 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 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 |
|---|---|---|---|
| * | K061754 | Bard Composite L/P MeshSummary page 1…1, § 878.3300, Product Code OQL - Class 11, § 876.1500, Product Code GCJ Predicate Device Names: * Bard Composixg L/P Mesh, K061754 (Davol Inc.), FDA cleared on 10/23/2006 * Surgical Structures Mesh GPSTM Deployment Balloon, K092726, FDA… | 2006 |
| * | K092726 | Mesh GPS - Large, Small, SM, SM SmallSummary page 1…te Device Names: * Bard Composixg L/P Mesh, K061754 (Davol Inc.), FDA cleared on 10/23/2006 * Surgical Structures Mesh GPSTM Deployment Balloon, K092726, FDA cleared on 03/15/2010 PREMARKET NOTIFICATION FOR THlE CopsT LIP MESH WITH… | 2010 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 3, 2014 | Class II | Z-0819-2014 | Labeling Change Control | Product labeling does not match product configuration. |
| Jan 3, 2014 | Class II | Z-0820-2014 | Labeling Change Control | Product labeling does not match product configuration. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 1 of the 24 ancestors has a recall of any class.
- Of its descendants, K110820 (C.R. Bard, Inc., 2011) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K061754.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Composix™ L/P Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. The Echo PS™ Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during laparoscopic hernia repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102766 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102766: Composix L/P Mesh with Echo PS Positioning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102766
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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