# K040835: Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16

- Pathway: 510(k) (Traditional)
- Applicant: Pm Devices, Inc.
- Decided: Jun 15, 2004 after 76 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K842066 (1985). 10 ancestors in all.
17 later devices descend from it; 5 cite it directly.
1 of 28 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031948: Peripatch Sheet, Models 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16, Pm Devices, Inc. (2003) Summary page 1.
- K983162: Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc, Bio-Vascular, Inc. (1998) Summary page 1.
- K963967: Glycar Pericardial Patch, Glycar, Inc. (1997) Summary page 1.
- K942010: Vascu-Guard, Bio-Vascular, Inc. (1994) Summary page 1.
- K921895: Tissue Patch, Tissue Graft, Bio-Vascular, Inc. (1992) Summary page 1.
- K830863: Hancock Pericardial Patch, Extracorporeal Medical Specialities, Inc. (1983) Summary page 1.

## Most influential descendants
- K090288: Orthadapt PR (2009), 7 descendants of its own
- K112786: Proseries Bioimplants-Proankle/Procuff (2011), 5 descendants of its own
- K082139: Edwards Bovine Pericardial Patch, Model 4700 (2008), 5 descendants of its own
- K220091: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (2022), 4 descendants of its own
- K130872: Cardiocel (2014), 3 descendants of its own

## Indications for use
Surgical patch material for cardiac and vascular reconstruction and repair. ... soft tissue deficiency repair and reinforcing the suture line during general surgical procedures.

Source page: https://510kreport.com/device/K040835
Methodology: https://510kreport.com/methodology