Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Drtech Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
164 daysmedian FDA review time
186 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132842 | FLAATZ 600 SERIES (FLAATZ 600/601) | Drtech Corp. | 2014-02-21 | 164 | 0 |
| K111655 | FLAATZ 760 | Drtech Corp. | 2011-11-30 | 170 | 0 |
| K111583 | FLAATZ 560 | Drtech Corp. | 2011-10-04 | 119 | 0 |
| K102474 | FLAATZ 750E | Drtech Corp. | 2011-03-04 | 186 | 0 |
| K091747 | FLAATZ 500 | Drtech Corp. | 2009-07-01 | 15 | 0 |
| K080064 | FLAATZ 750 | Drtech Corp. | 2008-01-23 | 13 | 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