510(k) Report

FDA applicant

Motiva USA, LLC

New York, NY3 decisions2019–20240 recalls

FDA records 3 decisions for Motiva USA, LLC (New York, NY) from 2019 to 2024: 2 510(k) clearances and 1 original PMA approval. Most are in product codes MRD (Mammary Sizer) and LCJ (Tissue Expander And Accessories). Its devices cite 2 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 Motiva USA, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2019: 12023: 12024: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Motiva USA, LLC by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MRDMammary Sizer1decision
  • LCJTissue Expander And Accessories1decision
  • FTRProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K183163Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant MatrixMotiva USA, LLC · 20191cites it

What has FDA decided for it lately?

  • P230005Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone…Motiva USA, LLC · 2024
  • K211676Motiva Flora SmoothSilk Tissue ExpanderMotiva USA, LLC · 2023
  • K183163Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant MatrixMotiva USA, LLC · 2019

All 3 as Motiva USA, LLC →