E K Ind., Inc.: FDA clearances and approvals
E K Ind., Inc. has 50 FDA 510(k) clearances (first 1984, latest 1984), across 34 product codes in 4 review panels. Median 510(k) review time: 44 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 |
|---|---|---|---|
| GGK | Products, Red-Cell Lysing Products | 4 | 4 |
| HZJ | Stain, Papanicolau | 4 | 4 |
| KIP | Formulations, Balanced Salt Solutions | 3 | 3 |
| HYJ | Hematoxylin | 2 | 2 |
| HZT | Reagent, Schiff | 2 | 2 |
| IAF | Wright'S Stain | 2 | 2 |
| JCC | Ph Buffer | 2 | 2 |
| KFC | Methylene Blue, Tissue Stain | 2 | 2 |
| LDW | Fixative, Acid Containing | 2 | 2 |
| LED | Stains, Chemical Solution | 2 | 2 |
Plus 24 more product codes.
Review panels
- Pathology (41)
- Hematology (6)
- Clinical Chemistry (1)
- General and Plastic Surgery (1)
Most recent E K Ind., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K842931 | DRABKIN REAGENT | KAG | 1984-09-21 | 58 |
| K842938 | ACETIC ACID 1% V/V | GGK | 1984-09-14 | 51 |
| K842937 | ACETIC ACID 2% V/V | GGK | 1984-09-12 | 49 |
| K842936 | ACETIC ACID, 3% V/V | GGK | 1984-09-12 | 49 |
| K842935 | ACETIC ACID, 5% V/V | GGK | 1984-09-12 | 49 |
| K842934 | DECOLORIZING FLUIC, ACID-ALCOHOL 3% | PPM | 1984-09-12 | 49 |
| K842933 | CARBOL-FUCHSIN, ZIEHL-NEEDSEN | ICL | 1984-09-11 | 48 |
| K842930 | GOMORI'S TRICHROME STAIN | LED | 1984-09-11 | 48 |
| K842928 | JENNER BLOOD STAIN | KJX | 1984-09-11 | 48 |
| K842927 | LIGHT GREEN SF 1% | HYS | 1984-09-11 | 48 |
40 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named E K Ind., Inc..
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 E K Ind., Inc. have?
E K Ind., Inc. has 50 FDA 510(k) clearances (first 1984, latest 1984), across 34 product codes in 4 review panels.
How long does FDA take to clear E K Ind., Inc.'s 510(k)s?
The median time from FDA receipt to decision across E K Ind., Inc.'s cleared 510(k)s is 44 days.
What devices does E K Ind., Inc. make?
Its most frequent FDA product codes are GGK (Products, Red-Cell Lysing Products, 4); HZJ (Stain, Papanicolau, 4); KIP (Formulations, Balanced Salt Solutions, 3).
Has E K Ind., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching E K Ind., Inc. Related entities may recall under other names.
Next steps
- See all 50 E K Ind., Inc. clearances with predicates and recalls
- Run predicate analysis for product code GGK, E K Ind., Inc.'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.