Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
IXO · 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) |
|---|---|---|---|---|---|
| K854976 | RMI RESPIRATORY GATING SYSTEM MODEL 301 | Radiation Measurements, Inc. | 1986-05-07 | 146 | 0 |
| K811587 | SIEMENS ANGIOTRON | Siemens Corp. | 1981-07-10 | 35 | 0 |
| K810588 | SYNCHRONIZER #208 | Brattle Instrument Corp. | 1981-04-10 | 37 | 0 |
| K791959 | POST EXTRA SYSTOLIC POSTENTLATOR | Medrad, Inc. | 1980-01-09 | 100 | 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