Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EYC · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
182 daysmedian FDA review time
311 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200757 | Foley Catheter with Temperature Sensor | Deroyal Industries, Inc. | 2020-10-15 | 205 | 0 |
| K061918 | FOLEY CATHETERS WITH TEMPERATURE PROBE | GE Healthcare | 2006-08-18 | 43 | 0 |
| K041416 | EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER | Deroyal | 2004-07-02 | 36 | 0 |
| K925790 | EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S | Deroyal Industries, Inc. | 1993-05-17 | 182 | 0 |
| K890310 | STERILE FOLEY CATHETER | Kosan Far East Ent. , Ltd. | 1989-11-30 | 311 | 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