Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American White Cross, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
187 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964614 | ULTRAFERA WOUND DRESSING | American White Cross, Inc. | 1997-02-06 | 80 | 0 |
| K962400 | AIR MAX EXTERNAL NASAL DILATOR STRIP | American White Cross, Inc. | 1996-09-09 | 80 | 0 |
| K894802 | AWC BUTTERFLY WOUND CLOSURES | American White Cross, Inc. | 1990-01-31 | 187 | 0 |
| K854809 | WHITE CROSS STERILE PAD 4IN. X 4IN. | American White Cross, Inc. | 1986-01-13 | 41 | 0 |
| K853558 | DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ | American White Cross, Inc. | 1985-09-05 | 10 | 0 |
| K853334 | NON-ADHERA ADHESIVE PAD 3X4 | American White Cross, Inc. | 1985-08-21 | 12 | 0 |
| K852408 | EXTRA LARGE ADHESIVE STRIPS | American White Cross, Inc. | 1985-07-29 | 53 | 0 |
| K852412 | NON-ADHERENT PAD | American White Cross, Inc. | 1985-07-29 | 53 | 0 |
| K852462 | TRICOT ADHESIVE BANDAGE | American White Cross, Inc. | 1985-07-26 | 46 | 0 |
| K850595 | 3 X 4 NON-ADHERENT PAD | American White Cross, Inc. | 1985-03-11 | 24 | 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