Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NWE · 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) |
|---|---|---|---|---|---|
| K140920 | SYNGO.CT COLONOGRAPHY | Siemens Medical Solutions USA, Inc. | 2014-12-03 | 237 | 0 |
| K083423 | COLONCAD API 3.1 | Medicsight Plc | 2011-05-17 | 909 | 0 |
| K042674 | COLON CAR 1.2 | Medicsight | 2004-10-19 | 20 | 0 |
| K042605 | COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY | Siemens AG Medical Solutions | 2004-10-08 | 14 | 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