Dumex Medical Surgical Products, Ltd.: FDA clearances and approvals
Dumex Medical Surgical Products, Ltd. has 13 FDA 510(k) clearances (first 1994, latest 2000), across 7 product codes in 2 review panels. Median 510(k) review time: 63 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | 3 | 3 |
| FRO | Dressing, Wound, Drug | 3 | 3 |
| KMF | Bandage, Liquid | 2 | 2 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 2 | 2 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 | 1 |
| NAD | Dressing, Wound, Occlusive | 1 | 1 |
Review panels
Most recent Dumex Medical Surgical Products, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992732 | STERILE WATER & STERILE 0.9% SODIUM CHLORIDE | FOZ | 2000-04-20 | 251 |
| K993119 | STERILE HYDROGEL | MGQ | 1999-11-23 | 64 |
| K990332 | DUMEX IODOFORM PACKING STRIP | FRO | 1999-04-14 | 70 |
| K980779 | THALAFIX NATURAL SEA SALT DRESSING | KMF | 1998-06-26 | 116 |
| K980861 | DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL | MGQ | 1998-05-20 | 76 |
| K980863 | DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC) | KMF | 1998-05-11 | 67 |
| K980777 | DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING | FRO | 1998-05-04 | 63 |
| K980791 | DUMEX PAK-ITS WOVEN RIBBON PACKING | EFQ | 1998-04-29 | 58 |
| K960815 | DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL | NAD | 1996-04-29 | 61 |
| K950132 | DUMEX WET DRESSINGS | FRO | 1995-03-01 | 47 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dumex Medical Surgical Products, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Dumex Medical Surgical Products, Ltd. have?
Dumex Medical Surgical Products, Ltd. has 13 FDA 510(k) clearances (first 1994, latest 2000), across 7 product codes in 2 review panels.
How long does FDA take to clear Dumex Medical Surgical Products, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Dumex Medical Surgical Products, Ltd.'s cleared 510(k)s is 63 days.
What devices does Dumex Medical Surgical Products, Ltd. make?
Its most frequent FDA product codes are EFQ (Gauze/Sponge, Internal, 3); FRO (Dressing, Wound, Drug, 3); KMF (Bandage, Liquid, 2).
Has Dumex Medical Surgical Products, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Dumex Medical Surgical Products, Ltd. Related entities may recall under other names.
Next steps
- See all 13 Dumex Medical Surgical Products, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EFQ, Dumex Medical Surgical Products, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.