Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lorrex Health Products · Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
57 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K945335 | CHERRY DISSECTOR | Lorrex Health Products | 1994-12-28 | 57 | 0 |
| K945866 | CYLINDRICAL SPONGE | Lorrex Health Products | 1994-12-28 | 27 | 0 |
| K945606 | TRIANGULAR SPONGES | Lorrex Health Products | 1994-12-28 | 43 | 0 |
| K945553 | ROUND STICK SPONGES, FLAT STICK SPONGES | Lorrex Health Products | 1994-12-28 | 48 | 0 |
| K945333 | KITTNER DISSECTOR | Lorrex Health Products | 1994-12-28 | 57 | 0 |
| K945336 | PEANUT DISSECTOR | Lorrex Health Products | 1994-12-05 | 34 | 0 |
| K945334 | CHERRY PIT DISSECTOR | Lorrex Health Products | 1994-12-05 | 34 | 0 |
| K945332 | ROSEBUD DISSECTOR | Lorrex Health Products | 1994-12-05 | 34 | 0 |
| K942824 | LORREX IV SPONGES, STERILE 2'S; LORREX DRAIN SPONGES, STERIL | Lorrex Health Products | 1994-08-03 | 50 | 0 |
| K942314 | LORREX GAUZE SPONGES SPECIALTY | Lorrex Health Products | 1994-06-02 | 20 | 0 |
| K942366 | LORREX GAUZE SPONGES, X-RAY DETECTABLE | Lorrex Health Products | 1994-05-27 | 9 | 0 |
| K942070 | LORREX COVER SPONGES STERILE2'S AND NON-STERILE | Lorrex Health Products | 1994-05-19 | 20 | 0 |
| K942071 | LORREX NON-WOVEN SPONGES NON-STERILE | Lorrex Health Products | 1994-05-19 | 20 | 0 |
| K942106 | SUPER/FLUFF SPONGES | Lorrex Health Products | 1994-05-19 | 17 | 0 |
| K941955 | LOREX TRACHEOSTOMY GAUZE SPONGES - STERILE 1'S AND 2'S | Lorrex Health Products | 1994-05-12 | 20 | 0 |
| K923225 | LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME | Lorrex Health Products | 1993-06-08 | 342 | 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