Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Links Medical Products, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133934 | MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER | Links Medical Products, Inc. | 2014-05-02 | 130 | 0 |
| K131796 | MANUKA FILL WOUND DRESSING | Links Medical Products, Inc. | 2014-03-14 | 269 | 1 |
| K120976 | MANUKA IG | Links Medical Products, Inc. | 2012-05-23 | 51 | 0 |
| K121227 | MANUKA FILL | Links Medical Products, Inc. | 2012-05-23 | 30 | 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