Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Excel Scientific, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
139 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971286 | EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST | Excel Scientific, Inc. | 1997-05-08 | 31 | 0 |
| K970467 | EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT | Excel Scientific, Inc. | 1997-03-18 | 39 | 0 |
| K970424 | EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST | Excel Scientific, Inc. | 1997-03-06 | 30 | 0 |
| K970425 | EZ SURE URINE DIPSTICK PREGNANCY HOME TEST | Excel Scientific, Inc. | 1997-03-06 | 30 | 0 |
| K963231 | EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST | Excel Scientific, Inc. | 1996-12-04 | 107 | 0 |
| K962146 | EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT | Excel Scientific, Inc. | 1996-10-07 | 126 | 0 |
| K962580 | EZ SURE ONESTEP EARLY PREGNANCY TEST | Excel Scientific, Inc. | 1996-08-29 | 59 | 0 |
| K955707 | ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT | Excel Scientific, Inc. | 1996-05-02 | 139 | 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