Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ETP — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
63 daysmedian FDA review time
225 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K863615 | ENTHERMO IRRIGATION UNIT | Jedmed Instrument Co. | 1986-12-16 | 91 | 0 |
| K820775 | VESTIBULARISET | Jedmed Instrument Co. | 1982-11-03 | 225 | 0 |
| K821481 | NASAL-THROAT SPRAY IRRIGATION INSTRUM. | Ethicare Products | 1982-06-14 | 27 | 0 |
| K813552 | MODEL 3000C CALORIC IRRIGATOR | Life-Tech Intl., Inc. | 1982-02-22 | 63 | 0 |
| K800442 | VARIOTHERM | Jedmed Instrument Co. | 1980-03-10 | 11 | 0 |
| K800443 | HYGROTHERM | Jedmed Instrument Co. | 1980-03-10 | 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