Roseburg SA: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Roseburg SA” (first 1985, latest 1994), across 19 product codes in 8 review panels. Median 510(k) review time under this name: 32 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 |
|---|---|---|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | 3 | 3 |
| HQZ | Frame, Spectacle | 3 | 3 |
| IOR | Wheelchair, Mechanical | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 | 1 |
| FXP | Cover, Shoe, Operating-Room | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| FYA | Gown, Surgical | 1 | 1 |
| FYF | Cap, Surgical | 1 | 1 |
| GBI | Material, External Aesthetic Restoration, Used With Adhesive | 1 | 1 |
Plus 9 more product codes.
Review panels
- Ophthalmic (8)
- General Hospital (4)
- Orthopedic (3)
- Physical Medicine (3)
- General and Plastic Surgery (3)
- Clinical Chemistry (1)
- Dental (1)
- Obstetrics and Gynecology (1)
Most recent Roseburg SA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931155 | STAPLE, FIXATION BONE; SCREW FIXATION BONE | HWC | 1994-09-01 | 541 |
| K890081 | CALIUS-ISABEL CANOVAS SUNGLASSES | HQY | 1989-03-09 | 58 |
| K885275 | ASSENAT-BLESCHET SUNGLASSES | HQY | 1989-01-24 | 28 |
| K882392 | BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES | KGO | 1988-08-26 | 77 |
| K872715 | UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY | JDN | 1987-12-07 | 150 |
| K874317 | POIRIER KID-ROLLER MANUAL WHEELCHAIR | IOR | 1987-11-17 | 27 |
| K872714 | S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY | GBI | 1987-07-21 | 11 |
| K871689 | SPECTACLE FRAME - LORRAINE | HQZ | 1987-05-29 | 30 |
| K871688 | SPECTACLE FRAME - DANIELLE | HQZ | 1987-05-29 | 30 |
| K870654 | EFER ARTHROSCOPE | HRX | 1987-05-14 | 90 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Roseburg SA.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Roseburg SA?
FDA lists 24 510(k) clearances under the applicant name “Roseburg SA” (first 1985, latest 1994), across 19 product codes in 8 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 Roseburg SA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Roseburg SA is 32 days.
Which FDA product codes appear under Roseburg SA?
The most frequent FDA product codes under this applicant name are HQY (Sunglasses (Non-Prescription Including Photosensitive), 3); HQZ (Frame, Spectacle, 3); IOR (Wheelchair, Mechanical, 2).
Next steps
- See all 24 Roseburg SA clearances with predicates and recalls
- Run predicate analysis for product code HQY, Roseburg SA'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.