Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Scott Health Care · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
97 daysmedian FDA review time
176 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954275 | MEPORE PLUS (9X15CM) | Scott Health Care | 1995-12-27 | 105 | 0 |
| K954274 | MEPORE (6X7) | Scott Health Care | 1995-12-19 | 97 | 0 |
| K945206 | ALLDRESS MULTI LAYERED WOUND DRESSING | Scott Health Care | 1995-01-12 | 79 | 0 |
| K932743 | MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION | Scott Health Care | 1993-09-10 | 94 | 0 |
| K905439 | HYPERGEL PROTECTIVE WOUND GEL | Scott Health Care | 1991-05-29 | 176 | 0 |
| K910857 | ALLDRESS MULTI LAYERED WOUND DRESSING | Scott Health Care | 1991-04-12 | 43 | 0 |
| K905438 | NORMLGEL PROTECTIVE WOUND GEL | Scott Health Care | 1991-04-01 | 118 | 0 |
| K900421 | PROMISE ABSORBENT PROTECTIVE PAD | Scott Health Care | 1990-06-06 | 127 | 0 |
| K897142 | MESALT STERILE DRESSING | Scott Health Care | 1990-03-27 | 90 | 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