510(k) Report

FDA applicant

Biom'Up Sas

St-Priest, FR2 decisions2011–20121 recall

FDA records 2 decisions for Biom'Up Sas (St-Priest, FR) from 2011 to 2012: 2 510(k) clearances. Most are in product codes JXI (Cuff, Nerve) and NPL (Barrier, Animal Source, Intraoral). Its devices cite 5 predicates, 0 of them its own earlier devices. 1 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, neurology panel, where it files most

How often FDA has decided Biom'Up Sas’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2011: 12012: 1
2011high 1 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2011high 1 (2016) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Biom'Up Sas by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biom'Up Sas’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?

  • JXICuff, Nerve1decision
  • NPLBarrier, Animal Source, Intraoral1decision

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.

  • K103081Covaortho-Nerve Resorbable Collagen MembraneBiom'Up Sas · 20123cite it

What has FDA decided for it lately?

  • K103081Covaortho-Nerve Resorbable Collagen MembraneBiom'Up Sas · 2012
  • K103087Covamax Resorbable Collagen MembraneBiom'Up Sas · 20111 recall

All 2 as Biom'Up Sas →

What has been recalled?

1 recall linked to its devices; the latest:

  • K103087RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.Dec 2, 2016Class II