Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Custom Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
125 daysmedian FDA review time
324 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K965205 | TEFGEN - LS | American Custom Medical, Inc. | 1997-04-30 | 125 | 0 |
| K964656 | TEFGEN GUIDED TISSUE MEMBRANE | American Custom Medical, Inc. | 1997-02-10 | 82 | 0 |
| K944413 | ACM PTFE SURGICAL MESH | American Custom Medical, Inc. | 1994-11-09 | 62 | 0 |
| K935137 | TEFGEN-FD | American Custom Medical, Inc. | 1994-08-15 | 291 | 1 |
| K933800 | FLUOROFILM(R) | American Custom Medical, Inc. | 1994-06-24 | 324 | 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