# Biosphere Medical, S.A.

- Location (FDA's records): Roissy-En-France, FR
- FDA decisions: 18 (2000–2025): 17 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Biosphere Medical, S.A. (10); Biosphere Medical, Inc. (6); Biosphere Medical (2)
- Product codes: KRD (10), HCG (3), DQO (2), NOY (1), NAJ (1), DQX (1)
- 510(k) review time since 2016: median 72 days, against 89 for FDA's reviews in the same codes and years (4 of 7 faster)
- Predicates its devices cite: 25 (13 its own); citations of its devices by later devices: 40 (13 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Interventional Therapeutics Corp.: 3 (https://510kreport.com/company/interventional-therapeutics)
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Radius Medical Technologies, Inc.: 2 (https://510kreport.com/company/radius-medical-technologies)
- Target Therapeutics: 2 (https://510kreport.com/company/target-therapeutics)
- Biocompatibles UK Limited: 1 (https://510kreport.com/company/biocompatibles-uk)
- Boston Scientific, Target: 1 (https://510kreport.com/company/boston-scientific-target)
- Vascular Solutions, Inc.: 1 (https://510kreport.com/company/vascular-solutions)

## Firms that cite its devices most
- Boston Scientific Corp: 4 (https://510kreport.com/company/boston-scientific)
- MicroVention, Inc.: 3 (https://510kreport.com/company/microvention)
- Vascular Solutions, Inc.: 3 (https://510kreport.com/company/vascular-solutions)
- Concentric Medical, Inc.: 2 (https://510kreport.com/company/concentric-medical)
- Imbiotechnologies: 2 (https://510kreport.com/company/imbiotechnologies)
- Protein Polymer Technologies, Inc.: 1 (https://510kreport.com/company/protein-polymer-technologies)
- Ostial Solutions, LLC: 1 (https://510kreport.com/company/ostial-solutions)
- Suzhou Haowei Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/suzhou-haowei-medical-technology)

## Its most-cited devices
- K021397: Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization (2002), cited by 10
- K991549: Embosphere Microspheres (2000), cited by 7
- K010026: Embogold Microsphere (2001), cited by 4
- K052742: Hepasphere Microspheres (2006), cited by 3
- DEN160040: Embosphere Microspheres (2017), cited by 3
- K183120: EmboCube Embolization Gelatin (2019), cited by 3

## Recent decisions
- K250971: Embosphere Microspheres (May 16, 2025)
- K192480: Torpedo Gelatin Foam (Nov 21, 2019)
- K183120: EmboCube Embolization Gelatin (Aug 6, 2019)
- K183578: Torpedo Gelatin Foam (Jun 18, 2019)
- K181021: EmboCube Embolization Gelatin (Sep 27, 2018)
- K181300: Embosphere Microspheres (Jul 16, 2018)
- K172372: QuadraSphere Microspheres (Sep 6, 2017)
- DEN160040: Embosphere Microspheres (Jun 21, 2017)

Source page: https://510kreport.com/company/biosphere-medical