510(k) · Cleared
Cleared4DDOME
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cousin Biotech · FTL Mesh, Surgical, Polymeric
Cleared on Aug 22, 2007 as substantially equivalent to K033671 (W. L. Gore & Associates, Inc., 2003) and 2 other predicates after a 142-day review. Its family tree reaches back 7 generations to 1985.
- Decided
- Aug 22, 2007
- Review
- 142 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K842066 (1985). 41 ancestors in all, the oldest K810428 (1981). No later device cites it as a predicate yet.
- Root · 7 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 6 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 5 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 4 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 3 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 2 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 1 generation backK033671 Gore Bioabsorbable MeshW. L. Gore & Associates, Inc. · 2003
- This deviceK070918 4DDOMECousin Biotech · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −6 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −5 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −4 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −3 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −2 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −1 | K033671 | Gore Bioabsorbable Mesh | W. L. Gore & Associates, Inc. | 2003 | — |
| 0 (this device) | K070918 | 4DDOME | Cousin Biotech | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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? (3)
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 |
|---|---|---|---|
| * | K033671 | Gore Bioabsorbable MeshSummary page 1…Polymeric Surgical Mesh Classification Name: Polymeric Surgical Mesh Predicate Devices: WL Gore - Bio-Absorbable® Hernia plug - K033671 Bard - Perfix® plug mesh - K92291 6 Atrium - Atrium® self… | 2003 |
| * | K922916 | Bard Marlex Mesh DartSummary page 1…lymeric Surgical Mesh Predicate Devices: WL Gore - Bio-Absorbable® Hernia plug - K033671 Bard - Perfix® plug mesh - K92291 6 Atrium - Atrium® self forming plug - K930669 Device Description: The 4DDOME® device is comp… | 1992 |
| * | K930669 | Atrium Polypropylene MeshSummary page 1…e® Hernia plug - K033671 Bard - Perfix® plug mesh - K92291 6 Atrium - Atrium® self forming plug - K930669 Device Description: The 4DDOME® device is composed of a dome and onlay patch. The dome is made of 10 % light polypropylene and… | 1993 |
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 22 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 41 ancestors have a recall of any class.
- 6 other devices also cite its predicate K033671.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
4DDome® is a semi-resorbable surgical plug and mesh for abdominal reinforcement, including open surgical repair and reinforcement of iguinal and crural hernias.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070918 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070918: 4DDOME.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070918
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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