510(k) Report

FDA applicant

Mast Biosurgery

San Diego, CA2 decisions2008–20210 recalls

FDA records 2 decisions for Mast Biosurgery (San Diego, CA) from 2008 to 2021: 2 510(k) clearances. All are in product code FTL (Mesh, Surgical, Polymeric). Its devices cite 5 predicates, 0 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 Mast Biosurgery’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2008: 12021: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Mast Biosurgery by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FTLMesh, Surgical, Polymeric2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery · 20083cite it

What has FDA decided for it lately?

  • K200918SurgiWrap FROSTMast Biosurgery · 2021
  • K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery · 2008

All 2 as Mast Biosurgery →

Other applicant names beginning “Mast”

FDA records each applicant name separately; these may or may not be the same firm.

Mast Immunosystems 13Mast Biosurgery USA, Inc. 4Mast Group, Ltd. 1