Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KCN · 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) |
|---|---|---|---|---|---|
| K062540 | NASOPORE EAR, MODELS ND04, ND05 | Polyganics B.V., | 2006-10-18 | 49 | 0 |
| K973578 | INVOTEC EAR TAMPON (WICK) W/STRING | Invotec International, Inc. | 1997-11-06 | 48 | 0 |
| K920357 | ULTRACELL EAR WICK | Ultracell Medical Technologies, Inc. | 1993-02-01 | 371 | 6 |
| K791059 | POPE OTO-WICK, STERILE & NON-STERILE | Xomed, Inc. | 1979-07-17 | 39 | 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