510(k) · Cleared
ClearedBard Pelvisoft Acellular Collagen Biomesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · FTM Mesh, Surgical
Cleared on May 15, 2003 after a 17-day review. The FDA summary names its predicate without a number. 15 later devices descend from it.
- Decided
- May 15, 2003
- Review
- 17 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 1 citing it directly.
- This deviceK031332 Bard Pelvisoft Acellular Collagen BiomeshC.R. Bard, Inc. · 2003
- Descendant · cites it directly · 14 of its ownK082176 LTM-BPS Surgical MeshLifecell Corp. · 2008
- Descendant · 2 generations on · 11 of its ownK142326 HP Tissue MatrixLifecell Corporation · 2014
- Descendant · 2 generations on · 9 of its ownK151083 BioBridge Collagen MatrixFibralign Corporation · 2016
- Descendant · 3 generations on · 4 of its ownK222978 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
- Descendant · 3 generations on · 3 of its ownK230316 FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences · 2023 · Recalled
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K082176LTM-BPS Surgical MeshLifecell Corp. · 2008 · cites it directly14descendants
- K142326HP Tissue MatrixLifecell Corporation · 2014 · 2 generations on11descendants
- K151083BioBridge Collagen MatrixFibralign Corporation · 2016 · 2 generations on9descendants
- K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022 · 3 generations on4descendants
- K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences · 2023 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031332 | Bard Pelvisoft Acellular Collagen Biomesh | C.R. Bard, Inc. | 2003 | — |
| +1 | K082176 | LTM-BPS Surgical Mesh | Lifecell Corp. | 2008 | — |
| +2 | K142326 | HP Tissue Matrix | Lifecell Corporation | 2014 | — |
| +2 | K151083 | BioBridge Collagen Matrix | Fibralign Corporation | 2016 | — |
| +3 | K222978 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022 | — |
| +3 | K230316 | FlexBand; FlexPatch; FlexBand Plus | International Life Sciences | 2023 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 FTM? 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 FTM device
- #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 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 |
|---|---|---|---|
| * | — | Permacol® Acellular Collagen Matrix Named without a submission number | |
| * | — | SurgiSIS™ Named without a submission number |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082176 | LTM-BPS Surgical Mesh | 2008 | 14 |
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?
- Of its descendants, K082176 (Lifecell Corp., 2008) has gone furthest, with 14 descendants of its own.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 2025
MAUDE reports naming product code FTM, 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 | 9 | 104 | 7 | 60 |
| 2008 | 9 | 86 | 1 | 141 |
| 2009 | 7 | 86 | 0 | 476 |
| 2010 | 2 | — | 1 | 197 |
| 2011 | 6 | 100 | 8 | 288 |
| 2012 | 4 | 66 | 0 | 467 |
| 2013 | 4 | 123 | 0 | 3,351 |
| 2014 | 8 | 153 | 0 | 1,093 |
| 2015 | 4 | 316 | 0 | 977 |
| 2016 | 7 | 88 | 0 | 509 |
| 2017 | 9 | 147 | 0 | 529 |
| 2018 | 2 | — | 21 | 357 |
| 2019 | 6 | 107 | 4 | 418 |
| 2020 | 4 | 59 | 1 | 457 |
| 2021 | 4 | 61 | 1 | 369 |
| 2022 | 0 | — | 0 | 375 |
| 2023 | 2 | — | 1 | 485 |
| 2024 | 3 | 29 | 0 | 383 |
| 2025 | 1 | — | 0 | 232 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Bard® PelviSoft™ Acellular Collagen BioMesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for urethral procedures, vaginal prolapse, and reconstruction of the pelvic floor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031332: Bard Pelvisoft Acellular Collagen Biomesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031332
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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