Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rita Medical Systems, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
35 daysmedian FDA review time
208 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070101 | UNIBLATE ELECTROSURGICAL DEVICE | Rita Medical Systems, Inc. | 2007-02-14 | 35 | 0 |
| K062414 | VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION S | Rita Medical Systems, Inc. | 2007-02-01 | 168 | 1 |
| K062579 | OMNIPICC P.I. | Rita Medical Systems, Inc. | 2006-11-28 | 89 | 0 |
| K051102 | OMNIPICC PI | Rita Medical Systems, Inc. | 2005-11-23 | 208 | 0 |
| K050176 | VORTEX EZ VASCULAR ACCESS PORT | Rita Medical Systems, Inc. | 2005-02-25 | 30 | 0 |
| K032149 | RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR | Rita Medical Systems, Inc. | 2003-09-09 | 57 | 0 |
| K031926 | RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIE | Rita Medical Systems, Inc. | 2003-07-17 | 24 | 1 |
| K031257 | RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR | Rita Medical Systems, Inc. | 2003-05-02 | 11 | 0 |
| K030936 | RITA CLIPS FOR INFUSION PUMPS | Rita Medical Systems, Inc. | 2003-04-01 | 7 | 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