Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
JPH · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
31 daysmedian FDA review time
48 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K871076 | WINPETTE | Ulster Scientific, Inc. | 1987-03-23 | 5 | 0 |
| K860899 | DISPETTE II | Ulster Scientific, Inc. | 1986-04-14 | 35 | 0 |
| K852554 | SRT-SYSTEM | Microwave Development, Inc. | 1985-07-18 | 31 | 0 |
| K840500 | SEDIPLAST | Precision Technology, Inc. | 1984-02-21 | 15 | 0 |
| K831195 | WESTERGREN DISPETTE FOR ESR | Ulster Scientific, Inc. | 1983-05-09 | 27 | 0 |
| K823761 | ERYTHROCYTE & STAND SEDIMENT. RATE TUBE | Cordis Corp. | 1983-01-21 | 38 | 0 |
| K823368 | DADE ESR KIT | American Dade | 1982-12-28 | 48 | 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