DRTECH Corporation: FDA clearances and approvals
DRTECH Corporation has 33 FDA 510(k) clearances (first 2008, latest 2026), across 6 product codes in 1 review panel. Median 510(k) review time: 119 days. Since 2017 its median was 122 days, against 106 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 164 |
| 2015 | 3 | 132 |
| 2016 | 2 | 90 |
| 2017 | 3 | 29 |
| 2018 | 0 | — |
| 2019 | 3 | 24 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 46 |
| 2023 | 5 | 140 |
| 2024 | 5 | 215 |
| 2025 | 3 | 159 |
| 2026 | 2 | 168 |
Review time against the same product codes
Since 2017, DRTECH Corporation's cleared 510(k)s took a median 122 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 18 | 18 |
| KPR | System, X-Ray, Stationary | 5 | 5 |
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 3 | 3 |
| OWB | Interventional Fluoroscopic X-Ray System | 3 | 3 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
Review panels
- Radiology (33)
Most recent DRTECH Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260227 | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H | KPR | 2026-09-08 | 225 |
| K261413 | EXTRON 3;EXTRON 6 | OWB | 2026-08-19 | 111 |
| K250010 | EXTRON 3; EXTRON 5; EXTRON 7 | OWB | 2025-06-10 | 159 |
| K242770 | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG | MQB | 2025-03-20 | 188 |
| K243443 | EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP | MQB | 2025-03-19 | 133 |
| K242591 | XERO-alpha | EHD | 2024-11-01 | 63 |
| K242847 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA); | KPR | 2024-10-23 | 33 |
| K240243 | EConsole2 | LLZ | 2024-09-23 | 237 |
| K233530 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM) | KPR | 2024-07-26 | 267 |
| K232082 | EXPD 4343S | MQB | 2024-02-13 | 215 |
23 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named DRTECH Corporation.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does DRTECH Corporation have?
DRTECH Corporation has 33 FDA 510(k) clearances (first 2008, latest 2026), across 6 product codes in 1 review panel.
How long does FDA take to clear DRTECH Corporation's 510(k)s?
The median time from FDA receipt to decision across DRTECH Corporation's cleared 510(k)s is 119 days. Since 2017: 122 days, versus 106 days for all cleared 510(k)s in the same product codes.
What devices does DRTECH Corporation make?
Its most frequent FDA product codes are MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 18); KPR (System, X-Ray, Stationary, 5); LLZ (System, Image Processing, Radiological, 3).
Has DRTECH Corporation had device recalls?
openFDA lists no recalls under a recalling firm name matching DRTECH Corporation. Related entities may recall under other names.
Next steps
- See all 33 DRTECH Corporation clearances with predicates and recalls
- Run predicate analysis for product code MQB, DRTECH Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.