Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MMZ — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033335 | LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS | Siemens Medical Solutions USA, Inc. | 2003-11-25 | 40 | 1 |
| K954278 | BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005 | Beta Medical Products, Inc. | 1995-10-02 | 19 | 0 |
| K942445 | SYNERGY II | Synectics Medical, Inc. | 1994-11-22 | 183 | 0 |
| K942485 | MDT UROLOGY TABLE | Mdt Corp., Inc. | 1994-08-26 | 93 | 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