Cmt Medical Technologies, Ltd.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Cmt Medical Technologies, Ltd.” (first 1995, latest 2020), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 55 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 | 1 | 45 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 27 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cmt Medical Technologies, Ltd. took a median 27 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 100 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 4 | 4 |
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| KPR | System, X-Ray, Stationary | 2 | 2 |
| HKL | Retinoscope, Ac-Powered | 1 | 1 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 1 | 1 |
Review panels
- Radiology (11)
- Ophthalmic (1)
Most recent Cmt Medical Technologies, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202235 | ArtPIX DRF | JAA | 2020-09-03 | 27 |
| K162224 | ArtPix Mobile EZ2GO | KPR | 2016-09-22 | 45 |
| K110849 | PRESTODR 4143 | KPR | 2011-04-26 | 29 |
| K103038 | DUET DRF | JAA | 2011-03-29 | 166 |
| K100400 | PRESTODR PORTABLE | IZL | 2010-04-22 | 65 |
| K080890 | SMARTSPOT PRIMAX | LLZ | 2008-04-29 | 29 |
| K003438 | SMART RAD | MQB | 2001-07-03 | 239 |
| K001111 | PANORET, MODEL 1000A | HKL | 2000-07-07 | 92 |
| K991578 | SMARTSPOT 2000 | LLZ | 1999-06-03 | 28 |
| K961140 | FLUOROPLUS CARDIAC TV | JAA | 1996-09-20 | 183 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cmt Medical Technologies, Ltd..
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 Cmt Medical Technologies, Ltd.?
FDA lists 12 510(k) clearances under the applicant name “Cmt Medical Technologies, Ltd.” (first 1995, latest 2020), across 6 product codes in 2 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 Cmt Medical Technologies, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cmt Medical Technologies, Ltd. is 55 days.
Which FDA product codes appear under Cmt Medical Technologies, Ltd.?
The most frequent FDA product codes under this applicant name are JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 4); LLZ (System, Image Processing, Radiological, 3); KPR (System, X-Ray, Stationary, 2).
Next steps
- See all 12 Cmt Medical Technologies, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JAA, Cmt Medical Technologies, Ltd.'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.