Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Omnitech Systems, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
94 daysmedian FDA review time
347 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151976 | Omnitech HF Resection Electrodes, Omnitech HF Vaporization E | Omnitech Systems, Inc. | 2016-06-27 | 347 | 0 |
| K050454 | OMNITECH FULGURATING ELECTRODE | Omnitech Systems, Inc. | 2005-05-27 | 94 | 0 |
| K981463 | OMNITECH RESECTOSCOPE ROLLER ELECTRODE | Omnitech Systems, Inc. | 1998-07-17 | 85 | 0 |
| K981464 | OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE | Omnitech Systems, Inc. | 1998-07-10 | 78 | 0 |
| K964365 | RESECTOSCOPE CUTTING LOOP ELECTRODE | Omnitech Systems, Inc. | 1997-04-22 | 172 | 0 |
| K965093 | OMNITECH RESECTOSCOPE ROLLER ELECTRODE | Omnitech Systems, Inc. | 1997-03-19 | 90 | 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