Wuestec Medical, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Wuestec Medical, Inc.” (first 1993, latest 1999), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 83 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 |
|---|---|---|---|
| IYB | Tube Mount, X-Ray, Diagnostic | 2 | 2 |
| KPR | System, X-Ray, Stationary | 2 | 2 |
| IXQ | Table, Radiographic, Stationary Top | 1 | 1 |
| IZX | Collimator, Manual, Radiographic | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
| KXJ | Table, Radiologic | 1 | 1 |
| OWB | Interventional Fluoroscopic X-Ray System | 1 | 1 |
Review panels
- Radiology (9)
Most recent Wuestec Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993962 | PENSIL TRAUMA, MODEL WWS6100 | KPR | 1999-12-21 | 57 |
| K992603 | XRT 600 R/F, WRF 0600 | JAA | 1999-10-25 | 83 |
| K992103 | C-QUEST | OWB | 1999-09-01 | 71 |
| K981880 | DX-480, ADD ON DIGITAL IMAGER | KPR | 1998-10-20 | 145 |
| K974240 | LIGHTLINE-M | IZX | 1997-12-22 | 40 |
| K960083 | MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300 | IXQ | 1996-07-24 | 195 |
| K955414 | XRT 400 | KXJ | 1996-07-24 | 240 |
| K935123 | SUPERSTAND 300 | IYB | 1996-03-27 | 881 |
| K933253 | SUPERSTAND 3000 | IYB | 1993-08-16 | 45 |
Recalls
openFDA lists no recalls under a recalling firm named Wuestec Medical, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Wuestec Medical, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Wuestec Medical, Inc.” (first 1993, latest 1999), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Wuestec Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wuestec Medical, Inc. is 83 days.
Which FDA product codes appear under Wuestec Medical, Inc.?
The most frequent FDA product codes under this applicant name are IYB (Tube Mount, X-Ray, Diagnostic, 2); KPR (System, X-Ray, Stationary, 2); IXQ (Table, Radiographic, Stationary Top, 1).
Next steps
- See all 9 Wuestec Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYB, Wuestec Medical, 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.