510(k) Report

FDA applicant

Pm Devices, Inc.

Richmond, Bc, CA4 decisions2003–20070 recalls

FDA records 4 decisions for Pm Devices, Inc. (Richmond, Bc, CA) from 2003 to 2007: 4 510(k) clearances. Most are in product codes FTM (Mesh, Surgical) and DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe…). Its devices cite 13 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Pm Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pm Devices, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pm Devices, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FTMMesh, Surgical3decisions
  • DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene1decision

Whose devices does it build on?

Its devices cite 13 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K040835Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16Pm Devices, Inc. · 20045cite it
  • K031948Peripatch Sheet, Models 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16Pm Devices, Inc. · 20033cite it
  • K033985Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10Pm Devices, Inc. · 20041cites it

What has FDA decided for it lately?

  • 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
  • K031948Peripatch Sheet, Models 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16Pm Devices, Inc. · 2003

All 4 as Pm Devices, Inc. →