Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FZD · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172389 | ePTFE-Coated Auricular Implant | Implantech Associates, Inc. | 2018-07-18 | 344 | 0 |
| K863939 | POREX(TM) EAR PROSTHESIS | Porex Medical | 1986-10-24 | 14 | 0 |
| K844960 | CANAL WALL PROSTHESIS | Richards Medical Co., Inc. | 1985-02-26 | 67 | 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