Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diros Technology, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
269 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170708 | OWL RF INSULATED CANNULAE | Diros Technology, Inc. | 2017-06-27 | 111 | 0 |
| K150371 | Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannul | Diros Technology, Inc. | 2015-07-30 | 167 | 0 |
| K141586 | OWL CANNULAE | Diros Technology, Inc. | 2014-12-30 | 200 | 0 |
| K102566 | OWL CANNULAE | Diros Technology, Inc. | 2011-06-03 | 269 | 0 |
| K110593 | OWL RF PROBES | Diros Technology, Inc. | 2011-05-05 | 64 | 0 |
| K093185 | OWL UNIVERSAL RF SYSTEM URF-3AP (ML) | Diros Technology, Inc. | 2010-01-22 | 105 | 0 |
| K062758 | OWL URF-3AP | Diros Technology, Inc. | 2006-09-27 | 12 | 0 |
| K021869 | OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP | Diros Technology, Inc. | 2002-07-01 | 25 | 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