Bios S.R.L.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Bios S.R.L.” (first 2005, latest 2024), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 142 days. Since 2017 the median was 152 days, against 105 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 188 |
| 2016 | 2 | 168 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 209 |
| 2021 | 1 | 29 |
| 2022 | 0 | — |
| 2023 | 3 | 227 |
| 2024 | 2 | 41 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bios S.R.L. took a median 152 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 7 | 7 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 5 | 5 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 1 | 1 |
Review panels
Most recent Bios S.R.L. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243445 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) | GEX | 2024-12-30 | 54 |
| K241407 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) | GEX | 2024-06-14 | 28 |
| K230755 | NuEra Tight RF Model OptiStream | PBX | 2023-10-30 | 227 |
| K223856 | NuEra Tight RF Family | GEI | 2023-08-11 | 231 |
| K223907 | NuEra Tight RF Model APMD145.M70-US | PBX | 2023-05-02 | 125 |
| K210867 | NuEra Tight RF, NuEra Tight RF Plus | PBX | 2021-04-21 | 29 |
| K201239 | NuEra Tight Family, EMS Model | NGX | 2020-12-31 | 238 |
| K200359 | NuEra Tight, NuEra Tight EMS | PBX | 2020-08-11 | 180 |
| K161632 | FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) | GEX | 2016-12-08 | 178 |
| K153229 | Superbium | GEX | 2016-04-12 | 158 |
4 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2017-07-13.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Bios, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bios S.R.L.?
FDA lists 14 510(k) clearances under the applicant name “Bios S.R.L.” (first 2005, latest 2024), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bios S.R.L.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bios S.R.L. is 142 days. Since 2017: 152 days, versus 105 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Bios S.R.L.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 7); PBX (Massager, Vacuum, Radio Frequency Induced Heat, 5); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 14 Bios S.R.L. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Bios S.R.L.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.