Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Dumex Medical Surgical Products, Ltd. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
116 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992732 | STERILE WATER & STERILE 0.9% SODIUM CHLORIDE | Dumex Medical Surgical Products, Ltd. | 2000-04-20 | 251 | 0 |
| K993119 | STERILE HYDROGEL | Dumex Medical Surgical Products, Ltd. | 1999-11-23 | 64 | 0 |
| K990332 | DUMEX IODOFORM PACKING STRIP | Dumex Medical Surgical Products, Ltd. | 1999-04-14 | 70 | 0 |
| K980779 | THALAFIX NATURAL SEA SALT DRESSING | Dumex Medical Surgical Products, Ltd. | 1998-06-26 | 116 | 0 |
| K980861 | DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL | Dumex Medical Surgical Products, Ltd. | 1998-05-20 | 76 | 0 |
| K980863 | DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHL | Dumex Medical Surgical Products, Ltd. | 1998-05-11 | 67 | 0 |
| K980777 | DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING | Dumex Medical Surgical Products, Ltd. | 1998-05-04 | 63 | 0 |
| K980791 | DUMEX PAK-ITS WOVEN RIBBON PACKING | Dumex Medical Surgical Products, Ltd. | 1998-04-29 | 58 | 0 |
| K960815 | DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING | Dumex Medical Surgical Products, Ltd. | 1996-04-29 | 61 | 0 |
| K950132 | DUMEX WET DRESSINGS | Dumex Medical Surgical Products, Ltd. | 1995-03-01 | 47 | 0 |
| K946326 | DUTEX GAUZE BANDAGE | Dumex Medical Surgical Products, Ltd. | 1995-01-24 | 33 | 0 |
| K945830 | DUFLEX CONFORMING BANDAGE (STERILE/NON-STERILE) | Dumex Medical Surgical Products, Ltd. | 1995-01-11 | 43 | 0 |
| K941217 | DUPAQUE SPONGE | Dumex Medical Surgical Products, Ltd. | 1994-04-21 | 38 | 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