Medicatech USA: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Medicatech USA” (first 2008, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 104 days. Since 2017 the median was 151 days, against 59 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 | 1 | 92 |
| 2014 | 0 | — |
| 2015 | 1 | 85 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 48 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 151 |
| 2024 | 0 | — |
| 2025 | 1 | 248 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medicatech USA took a median 151 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 59 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | 6 | 6 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 3 | 3 |
| OWB | Interventional Fluoroscopic X-Ray System | 1 | 1 |
Review panels
- Radiology (10)
Most recent Medicatech USA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242731 | MasteRad MiniX Mobile Digital Imaging System (Mini-X) | OWB | 2025-05-16 | 248 |
| K230918 | MasterX 800 Series | MQB | 2023-09-01 | 151 |
| K190601 | MasteRad MX30 | KPR | 2019-04-25 | 48 |
| K143257 | KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System | KPR | 2015-02-06 | 85 |
| K130377 | KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM | MQB | 2013-05-17 | 92 |
| K112132 | KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM | MQB | 2011-11-18 | 115 |
| K102285 | KRYSTALRAD (ATAL8) | KPR | 2011-01-03 | 144 |
| K102284 | KRYSTALRAD 560 (FLAATZ 560) | KPR | 2011-01-03 | 144 |
| K082798 | DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000 | KPR | 2008-10-28 | 35 |
| K080582 | MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA | KPR | 2008-05-15 | 73 |
Recalls
openFDA lists no recalls under a recalling firm named Medicatech USA.
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 Medicatech USA?
FDA lists 10 510(k) clearances under the applicant name “Medicatech USA” (first 2008, latest 2025), across 3 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 Medicatech USA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medicatech USA is 104 days. Since 2017: 151 days, versus 59 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medicatech USA?
The most frequent FDA product codes under this applicant name are KPR (System, X-Ray, Stationary, 6); MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 3); OWB (Interventional Fluoroscopic X-Ray System, 1).
Next steps
- See all 10 Medicatech USA clearances with predicates and recalls
- Run predicate analysis for product code KPR, Medicatech USA'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.