Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DRTECH Corporation — Predicate Candidate Screening
25 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
237 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250010 | EXTRON 3; EXTRON 5; EXTRON 7 | DRTECH Corporation | 2025-06-10 | 159 | 0 |
| K242770 | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG | DRTECH Corporation | 2025-03-20 | 188 | 0 |
| K243443 | EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343 | DRTECH Corporation | 2025-03-19 | 133 | 0 |
| K242591 | XERO-alpha | DRTECH Corporation | 2024-11-01 | 63 | 0 |
| K242847 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A4 | DRTECH Corporation | 2024-10-23 | 33 | 0 |
| K240243 | EConsole2 | DRTECH Corporation | 2024-09-23 | 237 | 0 |
| K233530 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A4 | DRTECH Corporation | 2024-07-26 | 267 | 0 |
| K232082 | EXPD 4343S | DRTECH Corporation | 2024-02-13 | 215 | 0 |
| K232753 | EXPD 4343D; EXPD 3643D | DRTECH Corporation | 2023-11-16 | 69 | 0 |
| K231225 | EConsole1 | DRTECH Corporation | 2023-10-18 | 173 | 0 |
| K230871 | EXTRON 5; EXTRON 7 | DRTECH Corporation | 2023-08-17 | 140 | 0 |
| K231959 | EXPD 4357; EXPD 4357P | DRTECH Corporation | 2023-08-01 | 29 | 0 |
| K220073 | RMF-2000 | DRTECH Corporation | 2023-01-26 | 381 | 0 |
| K223124 | EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG | DRTECH Corporation | 2022-11-18 | 46 | 0 |
| K193017 | EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG | DRTECH Corporation | 2019-11-22 | 24 | 0 |
| K193031 | EXPD 4343P, EXPD 3643P | DRTECH Corporation | 2019-11-22 | 23 | 0 |
| K192400 | EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG | DRTECH Corporation | 2019-10-03 | 30 | 0 |
| K171137 | EVS 2430W, EVS 2430GW | DRTECH Corporation | 2017-05-15 | 28 | 0 |
| K170930 | RSM 2430C | DRTECH Corporation | 2017-04-27 | 29 | 0 |
| K162670 | RSM 1824C with RConsole1 | DRTECH Corporation | 2017-02-23 | 150 | 0 |
| K162555 | EVS 4343, EVS 4343G | DRTECH Corporation | 2016-12-21 | 99 | 0 |
| K162552 | EVS 3643, EVS 3643G | DRTECH Corporation | 2016-12-02 | 80 | 0 |
| K152172 | Econsole1 | DRTECH Corporation | 2015-12-14 | 132 | 0 |
| K151942 | EVS 3643 | DRTECH Corporation | 2015-10-21 | 99 | 0 |
| K142475 | EVS 4343 | DRTECH Corporation | 2015-01-15 | 134 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda