510(k) · Cleared
ClearedPeri-Guard Pericardium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Vascular, Inc. · FTM Mesh, Surgical
Cleared on Jun 13, 1996 as substantially equivalent to K842066 (Genetic Laboratories, Inc., 1985) and 1 other predicate after a 34-day review. Its family tree reaches back 1 generation to 1985. 1 of the 342 devices in its family, counting itself, has a Class I recall. 339 later devices descend from it.
- Decided
- Jun 13, 1996
- Review
- 34 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K842066 (1985). 2 ancestors in all. 339 later devices descend from it, 3 citing it directly. 1 of the 342 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- This deviceK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- Descendant · cites it directly · 336 of its ownK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 173 of its ownK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- Descendant · 2 generations on · 147 of its ownK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- Descendant · 3 generations on · 145 of its ownK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- Descendant · 4 generations on · 143 of its ownK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
Showing 5 of 339 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K111064 Tigerpaw System II4 generations on · 2011
Most influential descendants
Showing 5 of 339 · See all- K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…Bio-Vascular, Inc. · 1998 · cites it directly336descendants
- K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000 · 2 generations on173descendants
- K992537Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and…Bio-Vascular, Inc. · 2000 · 2 generations on147descendants
- K014183Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002 · 3 generations on145descendants
- K030782Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003 · 4 generations on143descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| 0 (this device) | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| +1 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| +2 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| +2 | 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 | — |
| +4 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 3 | 0 |
| 2002 | 6 | 0 |
| 2003 | 6 | 0 |
| 2004 | 10 | 0 |
| 2005 | 7 | 0 |
| 2006 | 8 | 0 |
| 2007 | 13 | 0 |
| 2008 | 17 | 0 |
| 2009 | 12 | 0 |
| 2010 | 13 | 0 |
| 2011 | 12 | 1 |
| 2012 | 15 | 0 |
| 2013 | 17 | 0 |
| 2014 | 20 | 0 |
| 2015 | 12 | 0 |
| 2016 | 20 | 0 |
| 2017 | 28 | 0 |
| 2018 | 17 | 0 |
| 2019 | 12 | 0 |
| 2020 | 10 | 0 |
| 2021 | 12 | 0 |
| 2022 | 15 | 0 |
| 2023 | 13 | 0 |
| 2024 | 12 | 0 |
| 2025 | 11 | 0 |
| 2026 | 15 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K842066 | Peri-Guard Pericardial PatchSummary page 1…1024 Tel: 651-796-7300 Fax: 651-642-9018 Fonda Burley At address above Peri-Guard Repair Patch Surgical Mesh Mesh, Surgical - 21 CFR 878.3300 FimM, oWV Peri-Guard K842066 (Device acting as its own predicate) and Supple Peri-Guard K923657 Peri-Guard® Repair Patch (Peri-Guard) is a biologic tissue pr… | 1985 |
| * | K923657 | Supple Peri-GuardSummary page 1…above Peri-Guard Repair Patch Surgical Mesh Mesh, Surgical - 21 CFR 878.3300 FimM, oWV Peri-Guard K842066 (Device acting as its own predicate) and Supple Peri-Guard K923657 Peri-Guard® Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. Th… | 1992 |
What descends from it? (339)
See all 3393 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K111064Tigerpaw System IILaax, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
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?
Peri-Guard is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric binding, muscle flap reinforcement, and hemias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961811: Peri-Guard Pericardium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961811
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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