510(k) · Cleared
ClearedSupple Peri-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 K921895 (Bio-Vascular, Inc., 1992) and 1 other predicate after a 34-day review. Its family tree reaches back 1 generation to 1992. 2 of the 412 devices in its family, counting itself, have a Class I recall. 409 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 K921895 (1992). 2 ancestors in all. 409 later devices descend from it, 5 citing it directly. 2 of the 412 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- This deviceK961810 Supple 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 · cites it directly · 284 of its ownK980431 SurgisisCook Biotech, Inc. · 1998
- Descendant · 2 generations on · 204 of its ownK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 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
Showing 5 of 409 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 409 · See all- K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…Bio-Vascular, Inc. · 1998 · cites it directly336descendants
- K980431SurgisisCook Biotech, Inc. · 1998 · cites it directly284descendants
- K992159Surgisis SlingCook Biotech, Inc. · 1999 · 2 generations on204descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| 0 (this device) | K961810 | Supple 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 |
| +1 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| +2 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| +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 | — |
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 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2002 | 11 | 0 |
| 2003 | 9 | 0 |
| 2004 | 11 | 0 |
| 2005 | 13 | 0 |
| 2006 | 13 | 0 |
| 2007 | 15 | 0 |
| 2008 | 22 | 0 |
| 2009 | 16 | 0 |
| 2010 | 14 | 0 |
| 2011 | 15 | 1 |
| 2012 | 17 | 0 |
| 2013 | 19 | 0 |
| 2014 | 24 | 1 |
| 2015 | 14 | 0 |
| 2016 | 25 | 0 |
| 2017 | 30 | 0 |
| 2018 | 17 | 0 |
| 2019 | 14 | 0 |
| 2020 | 10 | 0 |
| 2021 | 13 | 0 |
| 2022 | 18 | 0 |
| 2023 | 16 | 0 |
| 2024 | 13 | 0 |
| 2025 | 15 | 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.
2 devices in this family have 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 |
|---|---|---|---|
| * | K921895 | Tissue Patch, Tissue GraftSummary page 1…Supple Peri-Guard Pericardium Common Name: Surgical Mesh Classification Name: Mesh, Surgical 21 CFR 878.3300 Product Code: FTm ;O wV Predicate devices: Supple Peri-Guard K921895 and K923657 (Device acting as its own predicate) Device Description: Supple Peri-Guard® is prepared from bovine pericardium whi… | 1992 |
| * | K923657 | Supple Peri-GuardSummary page 1…Guard Pericardium Common Name: Surgical Mesh Classification Name: Mesh, Surgical 21 CFR 878.3300 Product Code: FTm ;O wV Predicate devices: Supple Peri-Guard K921895 and K923657 (Device acting as its own predicate) Device Description: Supple Peri-Guard® is prepared from bovine pericardium which is crossl… | 1992 |
What descends from it? (409)
See all 4095 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | 1998 | 336 |
| K980431 | Surgisis | 1998 | 284 |
| K983602 | CV Peri-Guard and Vascu-Guard | 1998 | 31 |
| K973552 | Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant Wrap | 1997 | 1 |
| K122306 | Synovis Collagen Matrix (TBD) | 2013 | 0 |
Has anything in its family been recalled? (2 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.
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?
For use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal and umbilical).
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/K961810 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961810: Supple Peri-Guard Pericardium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961810
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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