510(k) · Cleared
ClearedPeripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10
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 4, 2004 as substantially equivalent to K031948 (Pm Devices, Inc., 2003) and 4 other predicates after a 164-day review. Its family tree reaches back 3 generations to 1985. 1 of the 11 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jun 4, 2004
- Review
- 164 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K842066 (1985). 9 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 11 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 deviceK033985 Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10Pm Devices, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK063556 Peripatch Endo-SleevePm Devices, Inc. · 2007
Class I recalls in this family
- K963967 Glycar Pericardial Patchdirect predicate · 1997
Most influential descendants
Showing 1 of 1 · See all- K063556Peripatch Endo-SleevePm Devices, Inc. · 2007 · cites it directly0descendants
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) | K033985 | Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10 | Pm Devices, Inc. | 2004 | — |
| +1 | K063556 | Peripatch Endo-Sleeve | Pm Devices, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|
| 2007 | 1 | 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? (5)
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 3510(k) Class PeriPatch T m Sheet PM Devices Inc. K031948 II Glycar Pericardial Patch Glycar Inc. K963967… | 2003 |
| * | K963967 | Glycar Pericardial PatchSummary page 1…PeriPatch T m Sheet PM Devices Inc. K031948 II Glycar Pericardial Patch Glycar Inc. K963967 Supple Peri-Guard® Pericardium BioVascular Inc. K983162 I [… | 1997 |
| * | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…Summary page 1…Glycar Pericardial Patch Glycar Inc. K963967 Supple Peri-Guard® Pericardium BioVascular Inc. K983162 I [ Vascu-Guard BioVascular K942010… | 1998 |
| * | K942010 | Vascu-GuardSummary page 1…Supple Peri-Guard® Pericardium BioVascular Inc. K983162 I [ Vascu-Guard BioVascular K942010 Inc.… | 1994 |
| * | K921895 | Tissue Patch, Tissue GraftSummary page 1…Inc. Supple Pen-Guard BioVascular Inc K921895 All of the above previously cleared products are composed of p… | 1992 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063556 | Peripatch Endo-Sleeve | 2007 | 0 |
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 9 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K063556 (Pm Devices, Inc., 2007) has gone furthest, with 0 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?
The PeriPatch TM Sleeve is intended for use as a surgical patch mesh material to reinforce surgical staples during stapling procedures and for reinforcing suture lines for cardiovascular and general procedures. Stapling is carried out according to the stapler manufacture's instructions. The sleeves are intended for staple reinforcement during a number of resection techniques such as lung volume reductions, biopsies, lobectomies, gastric banding, rectal and vaginal prolapse, and urethral sling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033985 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033985: Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033985
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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