Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NKA · 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) |
|---|---|---|---|---|---|
| K190575 | iBreastExam | Ue Lifesciences, Inc. | 2019-07-16 | 132 | 0 |
| K181672 | SureTouch Mobile Pressure Mapping System | Sure, Inc. | 2019-06-28 | 368 | 0 |
| K142926 | iBreastExam | Ue Lifesciences, Inc. | 2015-04-23 | 197 | 0 |
| DEN020001 | BREASTVIEW VISUAL MAPPING SYSTEM | Assurance Medical | 2003-01-31 | 248 | 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