Sopro: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Sopro” (first 1997, latest 2023), across 8 product codes in 6 review panels. Median 510(k) review time under this name: 87 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 | 1 | 278 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 392 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sopro took a median 392 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 102 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 13 | 13 |
| EIA | Unit, Operative Dental | 3 | 3 |
| NBL | Light-Induced Fluorescence Caries Detector | 3 | 3 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 2 | 2 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
| MUH | System, X-Ray, Extraoral Source, Digital | 1 | 1 |
| NTN | Led Light Source | 1 | 1 |
Review panels
- General and Plastic Surgery (13)
- Dental (6)
- Gastroenterology and Urology (3)
- Obstetrics and Gynecology (1)
- Orthopedic (1)
- Radiology (1)
Most recent Sopro 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223470 | C50 | NBL | 2023-12-14 | 392 |
| K121685 | SOPROCARE | NBL | 2013-03-12 | 278 |
| K103813 | SOPRO 281 | NTN | 2011-03-22 | 83 |
| K092329 | SOPIX 2 | MUH | 2010-07-20 | 350 |
| K092583 | SOPROLIFE | NBL | 2010-01-13 | 145 |
| K082796 | SOPRO 184 CAMERA | GCJ | 2009-04-01 | 190 |
| K080122 | SOPRO 670 ARTHROSCOPIC PUMP | HRX | 2008-07-11 | 176 |
| K070783 | SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR | HIF | 2007-12-13 | 267 |
| K072912 | SOPRO 225 DUAL HALOGEN LIGHT SOURCE | GCJ | 2007-11-16 | 35 |
| K070102 | SOPRO 162 CAMERA | GCJ | 2007-02-20 | 41 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sopro.
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.
- Sopro - Acteon Group (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sopro?
FDA lists 25 510(k) clearances under the applicant name “Sopro” (first 1997, latest 2023), across 8 product codes in 6 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 Sopro?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sopro is 87 days.
Which FDA product codes appear under Sopro?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 13); EIA (Unit, Operative Dental, 3); NBL (Light-Induced Fluorescence Caries Detector, 3).
Next steps
- See all 25 Sopro clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Sopro'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.