Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Excel Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
163 daysmedian FDA review time
315 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K932462 | VENTED NEEDLE | Excel Medical, Inc. | 1993-09-15 | 117 | 0 |
| K923966 | SYRINGE ADAPTOR | Excel Medical, Inc. | 1993-06-18 | 315 | 0 |
| K914988 | 500 INFUSER | Excel Medical, Inc. | 1992-04-06 | 152 | 1 |
| K913804 | EXCELSIOR SINGLE LEAD DISPENSING SET | Excel Medical, Inc. | 1992-02-11 | 169 | 1 |
| K905116 | PHARM-ASSIST | Excel Medical, Inc. | 1991-04-25 | 163 | 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