Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IXH · Predicate Candidate Screening
2 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023390 | MY BREAST FRIEND, BREAST SELF-EXAM PAD | Mbf Sales, LLC | 2002-11-26 | 48 | 0 |
| K851811 | SLIT CAMERA MODEL 07-624 | Victoreen, Inc. | 1985-05-28 | 32 | 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