Secol Co.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Secol Co.” (first 1980, latest 1981), across 12 product codes in 5 review panels. Median 510(k) review time under this name: 37 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| FQM | Bandage, Elastic | 3 | 3 |
| ITG | Bandage, Cast | 3 | 3 |
| KKX | Drape, Surgical, Antimicrobial | 3 | 3 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 | 1 |
| HMP | Pad, Eye | 1 | 1 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | 1 | 1 |
| HOZ | Sponge, Ophthalmic | 1 | 1 |
| ILH | Splint, Hand, And Components | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
Plus 2 more product codes.
Review panels
- General Hospital (6)
- General and Plastic Surgery (5)
- Physical Medicine (4)
- Ophthalmic (2)
- Orthopedic (1)
Most recent Secol Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K802790 | SOLVALINE | KKX | 1981-02-13 | 101 |
| K810111 | CELLONA PLASTER VARNISH | ITG | 1981-02-04 | 19 |
| K810110 | COBBLER'S CHIP SPLINTS | LGF | 1981-01-26 | 10 |
| K810109 | METAL SPLINTS | ILH | 1981-01-26 | 10 |
| K802794 | PRO-OPHTA STICKS | HOZ | 1980-12-22 | 48 |
| K802793 | LOMATUELL OINTMENT DRESSING | NAE | 1980-12-18 | 44 |
| K802799 | EYE PADS | HMP | 1980-12-17 | 43 |
| K802797 | O.R. DRAPES | KKX | 1980-12-17 | 43 |
| K802791 | ZINC PASTE BANDAGE | FRO | 1980-12-17 | 43 |
| K802787 | METALLINE DRESSINGS | KKX | 1980-12-17 | 43 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Secol Co..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Secol Co.?
FDA lists 18 510(k) clearances under the applicant name “Secol Co.” (first 1980, latest 1981), across 12 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Secol Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Secol Co. is 37 days.
Which FDA product codes appear under Secol Co.?
The most frequent FDA product codes under this applicant name are FQM (Bandage, Elastic, 3); ITG (Bandage, Cast, 3); KKX (Drape, Surgical, Antimicrobial, 3).
Next steps
- See all 18 Secol Co. clearances with predicates and recalls
- Run predicate analysis for product code FQM, Secol Co.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.