Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EZK · 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) |
|---|---|---|---|---|---|
| K911349 | E-Z-EM ENTEROCLYSIS CATHETER SET | E-Z-Em, Inc. | 1992-11-16 | 600 | 0 |
| K903816 | URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR | Respiratory Support Products, Inc. | 1990-10-31 | 72 | 0 |
| K770408 | KARAYA GUM POWDER, OSTOMY | Howmedica Corp. | 1977-03-15 | 11 | 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