Conco Medical Co.: FDA clearances and approvals
Conco Medical Co. has 12 FDA 510(k) clearances (first 1976, latest 1990), across 4 product codes in 3 review panels. Median 510(k) review time: 20 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 |
|---|---|---|---|
| FQM | Bandage, Elastic | 5 | 5 |
| ILH | Splint, Hand, And Components | 5 | 5 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| IMD | Pack, Hot Or Cold, Disposable | 1 | 1 |
Review panels
Most recent Conco Medical Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K904819 | SHUR-LOCK ICE WRAP SYSTEM | IMD | 1990-12-06 | 43 |
| K821701 | RAPIDO-LASTIC IN STERILE FORM | EFQ | 1982-07-22 | 44 |
| K820826 | STAX FINGER SPLINT | ILH | 1982-04-08 | 13 |
| K820382 | FROG SPLINT | ILH | 1982-03-01 | 20 |
| K820381 | FINGER PROTECTOR | ILH | 1982-03-01 | 20 |
| K820380 | CURVED FINGER SPLINT | ILH | 1982-03-01 | 20 |
| K820383 | FINGER COT | ILH | 1982-02-24 | 15 |
| K760142 | BANDAGE, RAPIDO-LASTIC COTTON/NYLON | FQM | 1976-07-19 | 20 |
| K760141 | BANDAGE, CONFO-LASTIC ALL COTTON ELASTIC | FQM | 1976-07-19 | 20 |
| K760140 | BANDAGE, WRINKY-LASTIC ELASTIC GAUZE | FQM | 1976-07-19 | 20 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Conco Medical Co..
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 Conco Medical Co. have?
Conco Medical Co. has 12 FDA 510(k) clearances (first 1976, latest 1990), across 4 product codes in 3 review panels.
How long does FDA take to clear Conco Medical Co.'s 510(k)s?
The median time from FDA receipt to decision across Conco Medical Co.'s cleared 510(k)s is 20 days.
What devices does Conco Medical Co. make?
Its most frequent FDA product codes are FQM (Bandage, Elastic, 5); ILH (Splint, Hand, And Components, 5); EFQ (Gauze/Sponge, Internal, 1).
Has Conco Medical Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Conco Medical Co. Related entities may recall under other names.
Next steps
- See all 12 Conco Medical Co. clearances with predicates and recalls
- Run predicate analysis for product code FQM, Conco Medical Co.'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.