510(k) Report

FDA applicant

Puregraft, LLC

Solana Beach, CA2 decisions2020–20200 recalls

FDA records 2 decisions for Puregraft, LLC (Solana Beach, CA) in 2020: 2 510(k) clearances. Most are in product codes MUU (System, Suction, Lipoplasty) and QPB (System, Suction, Lipoplasty For Removal). 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 Puregraft, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2020: 2
2020high 2 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Puregraft, LLC by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Puregraft, LLC’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?

  • MUUSystem, Suction, Lipoplasty1decision
  • QPBSystem, Suction, Lipoplasty For Removal1decision

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.

  • K193363Dermapose RefreshPuregraft, LLC · 20201cites it

What has FDA decided for it lately?

  • K200168Dermapose AccessPuregraft, LLC · 2020
  • K193363Dermapose RefreshPuregraft, LLC · 2020

All 2 as Puregraft, LLC →