Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bios S.R.L. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
158 daysmedian FDA review time
231 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243445 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) | Bios S.R.L. | 2024-12-30 | 54 | 0 |
| K241407 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) | Bios S.R.L. | 2024-06-14 | 28 | 0 |
| K230755 | NuEra Tight RF Model OptiStream | Bios S.R.L. | 2023-10-30 | 227 | 0 |
| K223856 | NuEra Tight RF Family | Bios S.R.L. | 2023-08-11 | 231 | 0 |
| K223907 | NuEra Tight RF Model APMD145.M70-US | Bios S.R.L. | 2023-05-02 | 125 | 0 |
| K210867 | NuEra Tight RF, NuEra Tight RF Plus | Bios S.R.L. | 2021-04-21 | 29 | 0 |
| K201239 | NuEra Tight Family, EMS Model | Bios S.R.L. | 2020-12-31 | 238 | 0 |
| K200359 | NuEra Tight, NuEra Tight EMS | Bios S.R.L. | 2020-08-11 | 180 | 0 |
| K161632 | FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) | Bios S.R.L. | 2016-12-08 | 178 | 0 |
| K153229 | Superbium | Bios S.R.L. | 2016-04-12 | 158 | 0 |
| K151296 | Family of Radiofrequency System (Biorevital RF MED, ThermiSm | Bios S.R.L. | 2015-11-19 | 188 | 0 |
| K080374 | BIOSYAG MEDICAL SYSTEM | Bios S.R.L. | 2008-05-15 | 93 | 0 |
| K072344 | APL MEDICAL SYSTEM | Bios S.R.L. | 2007-12-03 | 104 | 0 |
| K043521 | BIOSYAG 50 MED | Bios S.R.L. | 2005-03-24 | 94 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda