Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EYT — 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) |
|---|---|---|---|---|---|
| K934080 | URINARY DRAINAGE BAG | Kit Pak, Inc. | 1994-05-18 | 271 | 0 |
| K935774 | CURITY FAST-CATH FEMALE CATHETER KIT | Kendall Healthcare Products Co. Div.Of Tyco Health | 1994-04-11 | 129 | 0 |
| K883057 | COMFORT CATH MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | 1988-08-02 | 14 | 0 |
| K883119 | VPI NON-ADHESIVE CONDOM CATHETER | Cook Urological, Inc. | 1988-08-02 | 8 | 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