510(k) · Cleared
ClearedPeripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pm Devices, Inc. · FTM Mesh, Surgical
Cleared on Jun 15, 2004 as substantially equivalent to K031948 (Pm Devices, Inc., 2003) and 5 other predicates after a 76-day review. Its family tree reaches back 3 generations to 1985. 1 of the 28 devices in its family, counting itself, has a Class I recall. 17 later devices descend from it.
- Decided
- Jun 15, 2004
- Review
- 76 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K842066 (1985). 10 ancestors in all, the oldest K830863 (1983). 17 later devices descend from it, 5 citing it directly. 1 of the 28 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 2 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 1 generation backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- This deviceK040835 Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16Pm Devices, Inc. · 2004
- Descendant · cites it directly · 7 of its ownK090288 Orthadapt PRPegasus Biologics, Inc. · 2009
- Descendant · 2 generations on · 5 of its ownK112786 Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc. · 2011
- Descendant · cites it directly · 5 of its ownK082139 Edwards Bovine Pericardial Patch, Model 4700Edwards Lifesciences, LLC · 2008
- Descendant · 3 generations on · 4 of its ownK220091 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
- Descendant · 2 generations on · 3 of its ownK130872 CardiocelCelxcel Pty, Ltd. · 2014
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K963967 Glycar Pericardial Patchdirect predicate · 1997
Most influential descendants
Showing 5 of 17 · See all- K090288Orthadapt PRPegasus Biologics, Inc. · 2009 · cites it directly7descendants
- K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc. · 2011 · 2 generations on5descendants
- K082139Edwards Bovine Pericardial Patch, Model 4700Edwards Lifesciences, LLC · 2008 · cites it directly5descendants
- K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022 · 3 generations on4descendants
- K130872CardiocelCelxcel Pty, Ltd. · 2014 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −2 | 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 |
| 0 (this device) | K040835 | Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16 | Pm Devices, Inc. | 2004 | — |
| +1 | K090288 | Orthadapt PR | Pegasus Biologics, Inc. | 2009 | — |
| +2 | K112786 | Proseries Bioimplants-Proankle/Procuff | Synovis Orthopedic and Woundcare, Inc. | 2011 | — |
| +1 | K082139 | Edwards Bovine Pericardial Patch, Model 4700 | Edwards Lifesciences, LLC | 2008 | — |
| +3 | K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022 | — |
| +2 | K130872 | Cardiocel | Celxcel Pty, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 1 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K031948 | Peripatch Sheet, Models 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16Summary page 1…Predicate Device Manufacture I510(k) #(Class PeriPatch~ Sheet PM Devices Inc. K031948 1I Supple Peri-Guard® Pericardiurn BioVascular Inc. K(983162 1I… | 2003 |
| * | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…Summary page 1…PeriPatch~ Sheet PM Devices Inc. K031948 1I Supple Peri-Guard® Pericardiurn BioVascular Inc. K(983162 1I Glycar Pericardial Patch Glycar ~Inc. K963967 1… | 1998 |
| * | K963967 | Glycar Pericardial PatchSummary page 1…Supple Peri-Guard® Pericardiurn BioVascular Inc. K(983162 1I Glycar Pericardial Patch Glycar ~Inc. K963967 1 Vascu-Guard BioVascular Inc~. K942010 II… | 1997 |
| * | K942010 | Vascu-GuardSummary page 1…Glycar Pericardial Patch Glycar ~Inc. K963967 1 Vascu-Guard BioVascular Inc~. K942010 II Supple Pen-urd BioVascular Inc K(921895 II… | 1994 |
| * | K921895 | Tissue Patch, Tissue GraftSummary page 1…Vascu-Guard BioVascular Inc~. K942010 II Supple Pen-urd BioVascular Inc K(921895 II Hancock Pericardial Patch Extrcorpeal K(830863 II… | 1992 |
| * | K830863 | Hancock Pericardial PatchSummary page 1…Supple Pen-urd BioVascular Inc K(921895 II Hancock Pericardial Patch Extrcorpeal K(830863 II All of the above previously cleared products are composed of processed… | 1983 |
What descends from it? (17)
See all 175 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.
- K963967Glycar Pericardial PatchGlycar, Inc. · 1997 · Direct predicate · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K090288 (Pegasus Biologics, Inc., 2009) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K031948.
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?
Surgical patch material for cardiac and vascular reconstruction and repair.
... soft tissue deficiency repair and reinforcing the suture line during general surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040835 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040835: Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040835
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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