Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Science Incorporated — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K020881 | MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCE | Science Incorporated | 2002-03-27 | 9 | 0 |
| K010824 | PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT | Science Incorporated | 2001-06-05 | 78 | 0 |
| K990208 | PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT | Science Incorporated | 1999-03-25 | 63 | 0 |
| K971362 | PERSONAL INFUSOR | Science Incorporated | 1997-12-04 | 237 | 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