510(k) Report

FDA applicant

Biosphere Medical, S.A.

Roissy-En-France, FR18 decisions2000–20251 recall

FDA records 18 decisions for Biosphere Medical, S.A. (Roissy-En-France, FR) from 2000 to 2025: 17 510(k) clearances and 1 De Novo grant. Most are in product codes KRD (Device, Vascular, For Promoting Embolization) and HCG (Device, Neurovascular Embolization). Since 2016 its 510(k)s took a median of 72 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 25 predicates, 13 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Biosphere Medical, Inc.”, “Biosphere Medical”.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Biosphere Medical, S.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2012: 12015: 22017: 22018: 22019: 32025: 1
2007high 3 (2019) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2007high 1 (2026) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Biosphere Medical, S.A. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biosphere Medical, S.A.’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?

  • KRDDevice, Vascular, For Promoting Embolization10decisions
  • HCGDevice, Neurovascular Embolization3decisions
  • DQOCatheter, Intravascular, Diagnostic2decisions
  • NOYAgents, Embolic, For Treatment Of Benign Prostatic Hyperplasia1decision
  • NAJAgents, Embolic, For Treatment Of Uterine Fibroids1decision
  • DQXWire, Guide, Catheter1decision

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 72 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 89 days; 4 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 25 predicates; 13 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 40 times; 13 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.

  • K021397Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid EmbolizationBiosphere Medical, Inc. · 200210cite it
  • K991549Embosphere MicrospheresBiosphere Medical · 20007cite it
  • K010026Embogold MicrosphereBiosphere Medical, Inc. · 20014cite it
  • K052742Hepasphere MicrospheresBiosphere Medical, Inc. · 20063cite it
  • DEN160040Embosphere MicrospheresBiosphere Medical, S.A. · 20173cite it
  • K183120EmboCube Embolization GelatinBiosphere Medical, S.A. · 20193cite it

What has FDA decided for it lately?

  • K250971Embosphere MicrospheresBiosphere Medical, S.A. · 2025
  • K192480Torpedo Gelatin FoamBiosphere Medical, S.A. · 2019
  • K183120EmboCube Embolization GelatinBiosphere Medical, S.A. · 2019
  • K183578Torpedo Gelatin FoamBiosphere Medical, S.A. · 2019
  • K181021EmboCube Embolization GelatinBiosphere Medical, S.A. · 2018
  • K181300Embosphere MicrospheresBiosphere Medical, S.A. · 20181 recall
  • K172372QuadraSphere MicrospheresBiosphere Medical, S.A. · 2017
  • DEN160040Embosphere MicrospheresBiosphere Medical, S.A. · 2017

All 10 as Biosphere Medical, S.A. →All 6 as Biosphere Medical, Inc. →All 2 as Biosphere Medical →

What has been recalled?

1 recall linked to its devices; the latest:

  • K181300Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA…Aug 10, 2026Class II