Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
David A. Fuccillo, Ph.D. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
174 daysmedian FDA review time
205 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K935413 | ENA EIA TEST KIT | David A. Fuccillo, Ph.D. | 1994-06-02 | 205 | 0 |
| K935417 | JO-1 EIA TEST KIT | David A. Fuccillo, Ph.D. | 1994-05-05 | 177 | 0 |
| K935419 | LA EIA TEST KIT | David A. Fuccillo, Ph.D. | 1994-05-05 | 177 | 0 |
| K935418 | SCL-70 EIA TEST KIT | David A. Fuccillo, Ph.D. | 1994-05-05 | 177 | 0 |
| K940251 | MITOCHONDRIA EIA TEST KIT | David A. Fuccillo, Ph.D. | 1994-05-03 | 104 | 0 |
| K940253 | HISTONE EIA TEST KIT | David A. Fuccillo, Ph.D. | 1994-05-02 | 103 | 0 |
| K935415 | RNP EIA TEST KIT | David A. Fuccillo, Ph.D. | 1994-05-02 | 174 | 0 |
| K935416 | RO EIA TEST KIT | David A. Fuccillo, Ph.D. | 1994-05-02 | 174 | 0 |
| K935414 | SM EIA TEST KIT | David A. Fuccillo, Ph.D. | 1994-05-02 | 174 | 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