510(k) Report

510(k) · Cleared

Cleared

Peripatch Sheet, Models 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16

K031948510(k) TraditionalCleared Sep 16, 200384-day reviewClass II21 CFR 870.3470

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pm Devices, Inc. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Cleared on Sep 16, 2003 after an 84-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 36 later devices descend from it.

Decided
Sep 16, 2003
Review
84 days
Class
Class II
Product code
DXZ
Recalls
None
Predicates
0

36 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2004: 2 descendants cleared2007: 2 descendants cleared2020: 3 descendants cleared2008: 2 descendants cleared2009: 1 descendant cleared2010: 2 descendants cleared2019: 3 descendants cleared2013: 1 descendant cleared2021: 1 descendant cleared2011: 2 descendants cleared2016: 2 descendants cleared2014: 3 descendants cleared2017: 3 descendants cleared2012: 1 descendant cleared2022: 1 descendant cleared2018: 2 descendants cleared2025: 1 descendant cleared2023: 1 descendant cleared2026: 2 descendants cleared200020052010201520202025
  1. This deviceK031948 Peripatch Sheet, Models 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16Pm Devices, Inc. · 2003
  2. Descendant · cites it directly · 17 of its ownK040835 Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16Pm Devices, Inc. · 2004
  3. Descendant · cites it directly · 15 of its ownK051405 Regensis Pericardial PatchCormatrix Cardiovascular, Inc. · 2005
  4. Descendant · 2 generations on · 11 of its ownK063349 Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc. · 2007
  5. Descendant · 2 generations on · 7 of its ownK090288 Orthadapt PRPegasus Biologics, Inc. · 2009
  6. Descendant · 3 generations on · 5 of its ownK112786 Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc. · 2011

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2004: 22005: 12007: 22008: 22009: 12010: 22011: 22012: 12013: 12014: 32016: 22017: 32018: 22019: 32020: 32021: 12022: 12023: 12025: 12026: 2
2004high 3 (2014) · low 0 (2006)2026

Most influential descendants

Showing 5 of 36 · See all
  • K040835Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16Pm Devices, Inc. · 2004 · cites it directly17descendants
  • K051405Regensis Pericardial PatchCormatrix Cardiovascular, Inc. · 2005 · cites it directly15descendants
  • K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc. · 2007 · 2 generations on11descendants
  • K090288Orthadapt PRPegasus Biologics, Inc. · 2009 · 2 generations on7descendants
  • K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc. · 2011 · 3 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K031948Peripatch Sheet, Models 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16Pm Devices, Inc.2003—
+1K040835Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16Pm Devices, Inc.2004—
+1K051405Regensis Pericardial PatchCormatrix Cardiovascular, Inc.2005—
+2K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc.2007—
+2K090288Orthadapt PRPegasus Biologics, Inc.2009—
+3K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200510
200720
200820
200910
201020
201120
201210
201310
201430
201620
201730
201820
201930
202030
202110
202210
202310
202510
202620
FIG. 1 — Lineage of K031948, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DXZ? 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 DXZ device

  1. #1 K240775 PeriBeam® Pericardial Membranescore 9.2 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (36)

See all 36

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040835Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16Pm Devices, Inc.200417
K051405Regensis Pericardial PatchCormatrix Cardiovascular, Inc.200515
K033985Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10Pm Devices, Inc.20041

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K040835 (Pm Devices, Inc., 2004) has gone furthest, with 17 descendants of its own.

How does its category compare?

All DXZ devices

DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXZ

1in 2025

2007: 12008: 22009: 12010: 32011: 22012: 12013: 12014: 32015: 22016: 22017: 12020: 12025: 1
2007high 3 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXZ

106in 2014

2010: 91 days median2014: 106 days median
2007high 106 (2014) · low 91 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXZ

2in 2025

2010: 22011: 22013: 22018: 12020: 12023: 22025: 2, 2 Class I2026 (partial year): 1
2007high 2 (2010) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · DXZ

119in 2025

2007: 502008: 62009: 1092010: 812011: 472012: 212013: 692014: 932015: 1712016: 662017: 302018: 442019: 552020: 1212021: 802022: 772023: 402024: 492025: 119
2007high 171 (2015) · low 6 (2008)2025

MAUDE reports naming product code DXZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—050
20082—06
20091—0109
2010391281
20112—247
20121—021
20131—269
20143106093
20152—0171
20162—066
20171—030
20180—144
20190—055
20201—1121
20210—080
20220—077
20230—240
20240—049
20251—2 (2)119
20260—1—

What is it indicated for?

The PeriPatch Sheet is intended for use as a surgical patch material for cardiac and

vascular reconstruction and repair.

Indications for use as stated in the FDA 510(k) statement.

More from Pm Devices, Inc.

4 FDA decisions under this applicant name. See the company

  • K063556Peripatch Endo-SleevePm Devices, Inc. · 2007
  • K040835Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16Pm Devices, Inc. · 2004
  • K033985Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10Pm Devices, Inc. · 2004

Recent decisions in DXZ

The DXZ category page

  • K240775PeriBeam® Pericardial MembraneTamabio · 2025
  • K200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchVascutek, Ltd. · 2020
  • K162506PhotoFix Decellularized Bovine PericardiumCryolife, Inc. · 2017
  • K162579VascuCelAdmedus Regen Pty, Ltd. · 2016
  • K152127CorMatrix TykeCormatrix Cardiovascular, Inc. · 2016

https://510kreport.com/device/K031948 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031948: Peripatch Sheet, Models 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031948

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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