Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lorons International Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
57 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K951418 | LORREX GAUZE PADS (1'S) AND LORREX GAUZE SPONGES - STERILE 2 | Lorons International Corp. | 1995-04-14 | 17 | 0 |
| K945960 | LORREX NON-WOVEN SPONGES NON-STERILE, STERILE, DRESSINGS | Lorons International Corp. | 1995-01-12 | 36 | 0 |
| K942692 | LORREX HEALTH PRODUCTS-FLUFF GAUZE ROLLS; GAUZE CONFORMING B | Lorons International Corp. | 1994-08-03 | 57 | 0 |
| K943184 | LORREX HEALTH PROD COTTON FILLED SPONGES STERILE 2'S | Lorons International Corp. | 1994-08-03 | 33 | 0 |
| K942691 | LORREX POST OPERATIVE SPONGES | Lorons International Corp. | 1994-07-19 | 42 | 0 |
| K941956 | LORREX GAUZE PADS | Lorons International Corp. | 1994-05-19 | 27 | 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