Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dgh Technology, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
149 daysmedian FDA review time
249 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171301 | Scanmate Flex | Dgh Technology, Inc. | 2017-07-31 | 89 | 0 |
| K093371 | MODEL DGH 6000 SCANMATE A | Dgh Technology, Inc. | 2010-04-05 | 158 | 0 |
| K033385 | DGH 55 HANDHELD PACHYMETER (PACHMATE) | Dgh Technology, Inc. | 2003-11-07 | 15 | 0 |
| K965127 | DGH MODEL 9000 | Dgh Technology, Inc. | 1997-03-17 | 84 | 0 |
| K920906 | DGH-500 PACHYMETER | Dgh Technology, Inc. | 1992-11-02 | 249 | 0 |
| K913067 | DGH-4000 A-SCAN/PACHYMETER | Dgh Technology, Inc. | 1992-01-31 | 204 | 0 |
| K872726 | DGH-3000A A-SCAN | Dgh Technology, Inc. | 1987-12-04 | 149 | 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