510(k) · Cleared
Recalled · 2011Bard Soft Mesh, Models 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007
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 Mar 1, 2004 after an 83-day review. The FDA summary names its predicate without a number. 11 later devices descend from it. It has been recalled once.
- Decided
- Mar 1, 2004
- Review
- 83 days
- Class
- Class II
- Product code
- FTL
- Recalls
- 1
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK033814 Bard Soft Mesh, Models 0117001, 0117002, 0117003, 0117004, 0117005…C.R. Bard, Inc. · 2004
- Descendant · cites it directly · 5 of its ownK061445 Surgimesh WNAspide Medical · 2007 · Recalled
- Descendant · cites it directly · 4 of its ownK060237 CMB Antimicrobial DressingSilverleaf Medical Products, Inc. · 2006
- Descendant · 2 generations on · 3 of its ownK081977 Prosit Wound Treatment DeviceSilverleaf Medical Products, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK072974 Surgimesh XBAspide Medical · 2008 · Recalled
- Descendant · 2 generations on · 2 of its ownK130350 ProcelleraVomaris Innovations, Inc. · 2013
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K061445Surgimesh WNAspide Medical · 2007 · cites it directly5descendants
- K060237CMB Antimicrobial DressingSilverleaf Medical Products, Inc. · 2006 · cites it directly4descendants
- K081977Prosit Wound Treatment DeviceSilverleaf Medical Products, Inc. · 2008 · 2 generations on3descendants
- K072974Surgimesh XBAspide Medical · 2008 · cites it directly3descendants
- K130350ProcelleraVomaris Innovations, Inc. · 2013 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033814 | Bard Soft Mesh, Models 0117001, 0117002, 0117003, 0117004, 0117005, 0117006… | C.R. Bard, Inc. | 2004 | — |
| +1 | K061445 | Surgimesh WN | Aspide Medical | 2007 | 2 |
| +1 | K060237 | CMB Antimicrobial Dressing | Silverleaf Medical Products, Inc. | 2006 | — |
| +2 | K081977 | Prosit Wound Treatment Device | Silverleaf Medical Products, Inc. | 2008 | — |
| +1 | K072974 | Surgimesh XB | Aspide Medical | 2008 | 2 |
| +2 | K130350 | Procellera | Vomaris Innovations, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 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? (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 |
|---|---|---|---|
| * | — | Bard Mesh (Davol Inc.) Named without a submission number | |
| * | — | Atrium ProLite Ultra Mesh (Atrium Medical Corporation) Named without a submission number | |
| * | — | Ethicon Mersilene Polyester Fiber Mesh (Ethicon, Inc.) Named without a submission number |
What descends from it? (11)
See all 113 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 |
|---|---|---|---|---|
| Apr 25, 2011 | Not classified | Z-2239-2011 | Labeling mix-ups | Mislabeling: complaints of product labeled as Bard Soft Mesh 4" x 6" containing Bard Soft Mesh 6" x 6" |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061445 (Aspide Medical, 2007) has gone furthest, with 5 descendants of its own.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Indicated to reinforce soft tissue where weakness exists, i.e., repair of hernias and chest wall defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033814: Bard Soft Mesh, Models 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033814
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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