Solco Basle, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Solco Basle, Inc.” (first 1985, latest 1993), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 121 days. 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 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAC | Apparatus, Autotransfusion | 7 | 7 |
| CAK | Microfilter, Blood Transfusion | 1 | 1 |
| DWQ | Stripper, Vein, External | 1 | 1 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 1 | 1 |
Review panels
Most recent Solco Basle, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K913247 | SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM | CAC | 1993-02-25 | 584 |
| K913177 | SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM | CAC | 1993-02-25 | 589 |
| K915867 | SOLCOVAC WOUND DRAINAGE SYSTEM | GCY | 1992-08-14 | 227 |
| K896858 | SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM | CAC | 1990-04-05 | 121 |
| K896857 | SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM | CAC | 1990-04-05 | 121 |
| K896203 | SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER | CAK | 1990-02-01 | 98 |
| K883058 | SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEM | CAC | 1988-10-28 | 101 |
| K872590 | SOLCOTRANS CHEST DRAINAGE AUTOTRANSFUSION SYSTEM | CAC | 1987-09-04 | 65 |
| K872157 | HALL VEIN STRIPPER | DWQ | 1987-07-07 | 33 |
| K843821 | SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS | CAC | 1985-10-01 | 368 |
Recalls
openFDA lists no recalls under a recalling firm named Solco Basle, Inc..
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.
- Solco Biomedical Co., Ltd. (17 510(k)s)
- Solco Biomedical Company India Private Limited (2 510(k)s)
- Solco Biomedical Copany India Private Limited (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Solco Basle, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Solco Basle, Inc.” (first 1985, latest 1993), across 4 product codes in 3 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 Solco Basle, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Solco Basle, Inc. is 121 days.
Which FDA product codes appear under Solco Basle, Inc.?
The most frequent FDA product codes under this applicant name are CAC (Apparatus, Autotransfusion, 7); CAK (Microfilter, Blood Transfusion, 1); DWQ (Stripper, Vein, External, 1).
Next steps
- See all 10 Solco Basle, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAC, Solco Basle, Inc.'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.