Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Intact Medical Corporation · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K152596 | Intact® Gen2 System | Intact Medical Corporation | 2016-02-15 | 158 | 0 |
| K142477 | Intact Advance and Intact Excision XL, Intact BLES | Intact Medical Corporation | 2014-12-15 | 103 | 0 |
| K081057 | INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL | Intact Medical Corporation | 2008-06-17 | 64 | 0 |
| K060413 | INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE | Intact Medical Corporation | 2006-04-27 | 70 | 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