510(k) · Cleared
ClearedMesh GPS - Large, Small, SM, SM Small
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Structures, Ltd. · OQL Mesh, Surgical, Deployment Balloon
Cleared on Mar 15, 2010 as substantially equivalent to K041641 (C.R. Bard, Inc., 2004) and 7 other predicates after a 193-day review. Its family tree reaches back 4 generations to 1994. 7 later devices descend from it.
- Decided
- Mar 15, 2010
- Review
- 193 days
- Class
- Class II
- Product code
- OQL
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 4 generations to K944418 (1994). 23 ancestors in all, the oldest K926010 (1993). 7 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK944418 The Spacemaker and the Spacemaker IIGeneral Surgical Innovations · 1994
- 3 generations backK962702 Spacemaker Serial Surgical Balloon Dissector, with Cannula, with…General Surgical Innovations · 1997
- 2 generations backK973046 Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical…General Surgical Innovations · 1998
- 1 generation backK090631 Pajunk Disposable Balloons and Balloon SystemsPAJUNK GmbH Medizintechnologie · 2009
- This deviceK092726 Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010
- Descendant · cites it directly · 6 of its ownK102766 Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 5 of its ownK110820 Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011
- Descendant · 2 generations on · 4 of its ownK122436 Composix L/P Mesh with Echo PS Positioning System Ventralight ST…C.R. Bard, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 3 of its ownK130968 Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 2 of its ownK143743 ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHC.R. Bard, Inc. · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K102766Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · cites it directly6descendants
- K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011 · 2 generations on5descendants
- K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS…C.R. Bard, Inc. · 2012 · 2 generations on4descendants
- K130968Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2013 · 3 generations on3descendants
- K143743ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHC.R. Bard, Inc. · 2015 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944418 | The Spacemaker and the Spacemaker II | General Surgical Innovations | 1994 | — |
| −3 | K962702 | Spacemaker Serial Surgical Balloon Dissector, with Cannula, with Visualization… | General Surgical Innovations | 1997 | — |
| −2 | K973046 | Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon… | General Surgical Innovations | 1998 | — |
| −1 | K090631 | Pajunk Disposable Balloons and Balloon Systems | PAJUNK GmbH Medizintechnologie | 2009 | — |
| 0 (this device) | K092726 | Mesh GPS - Large, Small, SM, SM Small | Surgical Structures, Ltd. | 2010 | — |
| +1 | K102766 | Composix L/P Mesh with Echo PS Positioning System | C.R. Bard, Inc. | 2010 | 2 |
| +2 | K110820 | Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System | C.R. Bard, Inc. | 2011 | — |
| +2 | K122436 | Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with… | C.R. Bard, Inc. | 2012 | 15 |
| +3 | K130968 | Ventralight ST Mesh with Echo PS Positioning System | C.R. Bard, Inc. | 2013 | 4 |
| +3 | K143743 | ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH | C.R. Bard, Inc. | 2015 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 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 OQL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | K041641 | Davol Delivery SystemSummary page 1…stic and Reconstructive Surgery Branch. Predicate Devices * Davol Delivery System (currently marketed as PrecisionPass Laparoscopic Delivery Device), K04 1641 (Davol Inc.). * Bard Composix®V LIP Mesh, K06 1754 (Davol, Inc.). * Biomesh CA.B.S.'Air, K072962 (Cousin Biotech S.AS).… | 2004 |
| * | K061754 | Bard Composite L/P MeshSummary page 1…te Devices * Davol Delivery System (currently marketed as PrecisionPass Laparoscopic Delivery Device), K04 1641 (Davol Inc.). * Bard Composix®V LIP Mesh, K06 1754 (Davol, Inc.). * Biomesh CA.B.S.'Air, K072962 (Cousin Biotech S.AS). * DualMesh EMERGE Biomaterial and DualMesh EMERGE PL… | 2006 |
| * | K072962 | Cabs'airSummary page 1…arketed as PrecisionPass Laparoscopic Delivery Device), K04 1641 (Davol Inc.). * Bard Composix®V LIP Mesh, K06 1754 (Davol, Inc.). * Biomesh CA.B.S.'Air, K072962 (Cousin Biotech S.AS). * DualMesh EMERGE Biomaterial and DualMesh EMERGE PLUS Biomaterial, K022782 (W.L. Gore and Ass… | 2008 |
| * | K022782 | Dualmesh Emerge & Emerge Plus BiomaterialSummary page 1…P Mesh, K06 1754 (Davol, Inc.). * Biomesh CA.B.S.'Air, K072962 (Cousin Biotech S.AS). * DualMesh EMERGE Biomaterial and DualMesh EMERGE PLUS Biomaterial, K022782 (W.L. Gore and Associates, Inc). * Modified SPACEMAKER System, K042412 (United States Surgical). This is a special 5… | 2002 |
| * | K042412 | Modified Spacemaker SystemSummary page 1…Biotech S.AS). * DualMesh EMERGE Biomaterial and DualMesh EMERGE PLUS Biomaterial, K022782 (W.L. Gore and Associates, Inc). * Modified SPACEMAKER System, K042412 (United States Surgical). This is a special 5 10k on the SPACEMAKER* Dissection Balloon, K973046. *Hernia Mesh Stab… | 2004 |
| * | K981598 | Hernia Mesh StabilizerSummary page 1…ified SPACEMAKER System, K042412 (United States Surgical). This is a special 5 10k on the SPACEMAKER* Dissection Balloon, K973046. *Hernia Mesh Stabilizer, K981598 (Medivices Inc.). *PAJUNKs Balloons and Balloon systems, K090631I (Pajunk Medical Systems). *Rebound HRD, K063671 (Mi… | 1998 |
| * | K090631 | Pajunk Disposable Balloons and Balloon SystemsSummary page 1…special 5 10k on the SPACEMAKER* Dissection Balloon, K973046. *Hernia Mesh Stabilizer, K981598 (Medivices Inc.). *PAJUNKs Balloons and Balloon systems, K090631I (Pajunk Medical Systems). *Rebound HRD, K063671 (Minnesota Medical]Development,lInc. (MMDI)).… | 2009 |
| * | K063671 | Rebound HRDSummary page 1…on, K973046. *Hernia Mesh Stabilizer, K981598 (Medivices Inc.). *PAJUNKs Balloons and Balloon systems, K090631I (Pajunk Medical Systems). *Rebound HRD, K063671 (Minnesota Medical]Development,lInc. (MMDI)). Page 5-2 Z… | 2007 |
| † | K973046 | Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon Dissector, Saphtrak | 1998 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102766 | Composix L/P Mesh with Echo PS Positioning System | 2010 | 6 |
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 16 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 23 ancestors has a recall of any class.
- Of its descendants, K102766 (C.R. Bard, Inc., 2010) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K041641.
How does its category compare?
All OQL devicesOQL Mesh, Surgical, Deployment Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OQL
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · OQL
Too few OQL 510(k)s in any year since 2007 to give a median.
Recalls per year · OQL
No recall names OQL since 2007.
Adverse event reports per year · OQL
1in 2022
MAUDE reports naming product code OQL, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Mesh GPS device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092726 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092726: Mesh GPS - Large, Small, SM, SM Small.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092726
Report an extraction error
Are you the manufacturer?
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