Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
EIB · 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) |
|---|---|---|---|---|---|
| K911118 | DTF-1000LL,DTF-1000 | Cp Medical | 1991-11-20 | 253 | 0 |
| K874543 | MODEL OPO-32 IRRIGATION SLEEVE | Allergan, Inc. | 1988-01-14 | 72 | 0 |
| K822411 | SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 | Western Advanced Technology, Inc. | 1983-07-12 | 336 | 0 |
| K760570 | ROBINSON MIDDLE EAR PROSTHESIS | Xomed, Inc. | 1976-09-21 | 20 | 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