Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
NEC · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972081 | SUPERSKIN | Medlogic Global Corp. | 1997-12-17 | 197 | 0 |
| K861557 | APLICARE SKIN PROTECTANT PREP PAD | Aplicare, Inc. | 1986-07-11 | 77 | 0 |
| K861558 | APLICARE SKIN PROTECTANT SWABSTICK | Aplicare, Inc. | 1986-06-04 | 40 | 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