510(k) · Cleared
ClearedSupple Peri-Guard
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 Dec 21, 1992 after a 208-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 of the 415 devices in its family, counting itself, have a Class I recall. 414 later devices descend from it.
- Decided
- Dec 21, 1992
- Review
- 208 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 0
414 later devices descend from it, 9 citing it directly. 3 of the 415 devices in this family, counting this one, have a Class I recall.
- This deviceK923657 Supple Peri-GuardBio-Vascular, Inc. · 1992
- Descendant · cites it directly · 409 of its ownK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- Descendant · cites it directly · 339 of its ownK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- Descendant · 2 generations on · 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 · 285 of its ownK970561 Graft PatchOrganogenesis, Inc. · 1997
- Descendant · 2 generations on · 284 of its ownK980431 SurgisisCook Biotech, Inc. · 1998
Showing 5 of 414 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 414 · See all- K961810Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996 · cites it directly409descendants
- K961811Peri-Guard PericardiumBio-Vascular, Inc. · 1996 · cites it directly339descendants
- K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…Bio-Vascular, Inc. · 1998 · 2 generations on336descendants
- K970561Graft PatchOrganogenesis, Inc. · 1997 · cites it directly285descendants
- K980431SurgisisCook Biotech, Inc. · 1998 · 2 generations on284descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K923657 | Supple Peri-Guard | Bio-Vascular, Inc. | 1992 | — |
| +1 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| +1 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| +2 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| +1 | K970561 | Graft Patch | Organogenesis, Inc. | 1997 | — |
| +2 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 3 | 0 |
| 1997 | 3 | 1 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (414)
See all 4149 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K961810 | Supple Peri-Guard Pericardium | 1996 | 409 |
| K961811 | Peri-Guard Pericardium | 1996 | 339 |
| K970561 | Graft Patch | 1997 | 285 |
| K014183 | Afb (Absorbable Foam Buttress) | 2002 | 145 |
| K982330 | Depuy Orthotech Restore Orthobiologic Soft Tissue Implant | 1998 | 92 |
| K963967 | Glycar Pericardial Patch Class I | 1997 | 20 |
| K973552 | Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant Wrap | 1997 | 1 |
| K122306 | Synovis Collagen Matrix (TBD) | 2013 | 0 |
| K963175 | Glycar Tissue Repair Patch, Bio-Patch, Uro-Sling | 1996 | 0 |
Has anything in its family been recalled? (3 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.
- K963967Glycar Pericardial PatchGlycar, Inc. · 1997 · Cites it directly · ◆ in the 1997 descendants bar of FIG. 12 Class I recalls
- K142461VASCU-GUARD Peripheral Vascular PatchSynovis Life Technologies, Inc. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K111064Tigerpaw System IILaax, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K961810 (Bio-Vascular, Inc., 1996) has gone furthest, with 409 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 | — |
https://510kreport.com/device/K923657 · printed Nov 5, 2026
Cite this page
510(k) Report. “K923657: Supple Peri-Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K923657
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026