Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Excel Health Care Products · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
33 daysmedian FDA review time
372 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K850960 | NON-ABSORBENT DRAPES & ABSORBENT TOWELS | Excel Health Care Products | 1986-03-15 | 372 | 0 |
| K850456 | TRACHEOSTOMY CARE KIT | Excel Health Care Products | 1985-03-11 | 33 | 0 |
| K850326 | STERILE FILM DRAPE FENESTRATED W/ADHESIVE PATCH | Excel Health Care Products | 1985-02-26 | 29 | 0 |
| K850325 | STERILE SUTURE REMOVAL KIT | Excel Health Care Products | 1985-02-26 | 29 | 0 |
| K850199 | POLY-LINED TOWEL/DRAPE LINE | Excel Health Care Products | 1985-02-21 | 34 | 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