Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rita Medical Systems · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
26 daysmedian FDA review time
166 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062935 | HABIB 4X LAPAROSCOPIC | Rita Medical Systems | 2006-10-13 | 15 | 0 |
| K040989 | RITA SYSTEMS | Rita Medical Systems | 2004-04-28 | 12 | 1 |
| K030967 | RITA STARBURST SDE ELECTROSURGICAL DEVICE | Rita Medical Systems | 2003-04-21 | 26 | 0 |
| K023846 | MR COMPATIBLE RITA MODEL 90 ELECTOSURGICAL ACCESSORY | Rita Medical Systems | 2002-12-06 | 17 | 0 |
| K021329 | RITA SYSTEM | Rita Medical Systems | 2002-10-09 | 166 | 0 |
| K003676 | RITA MODEL 2500 ELECTROSURGICAL RF GENERATOR | Rita Medical Systems | 2001-04-09 | 131 | 0 |
| K010060 | RITA STARBURST XLI ELECTROSURGICAL DEVICE | Rita Medical Systems | 2001-01-23 | 15 | 2 |
| K983214 | RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES | Rita Medical Systems | 2000-03-27 | 560 | 0 |
| K993944 | RITA MODEL 1500 ELECTROSURGICAL GENERATOR, POWER CORD,FOOTSW | Rita Medical Systems | 1999-12-02 | 13 | 0 |
| K992693 | RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 90 | Rita Medical Systems | 1999-09-10 | 29 | 3 |
| K983871 | RITA MODEL 70 ELECTROSURGICAL PROBE | Rita Medical Systems | 1998-12-01 | 29 | 1 |
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