FDA applicant
Bios S.R.L.
FDA records 15 decisions for Bios S.R.L. (Vimodrone, IT) from 1978 to 2024: 15 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and PBX (Massager, Vacuum, Radio Frequency Induced Heat). Since 2016 its 510(k)s took a median of 168 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. Its devices cite 22 predicates, 9 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Bios, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bios S.R.L.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like Bios S.R.L.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report