Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
JAM · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K842895 | WBA - I.R.I.S. | Siemens Gammasonics, Inc. | 1984-08-27 | 35 | 0 |
| K841996 | MAXICAMERA 400T W/BODY CONTOUR TOMOGRA | General Electric Co. | 1984-07-16 | 61 | 0 |
| K770530 | CLEON IMAGER | Union Carbide Corp. | 1977-04-05 | 15 | 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