Medcomp Technologies, Inc.: FDA clearances and approvals
Medcomp Technologies, Inc. has 5 FDA 510(k) clearances (first 1986, latest 1986), across 4 product codes in 1 review panel. Median 510(k) review time: 14 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 |
|---|---|---|---|
| GEN | Forceps, General & Plastic Surgery | 1 | 1 |
| HRQ | Hemostat | 1 | 1 |
| KDA | Prosthesis, Ptfe/Carbon-Fiber | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Medcomp Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861807 | MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP) | HRQ | 1986-05-23 | 14 |
| K861806 | MEDCARE SUTURE SCISSORS (SUTURE/GAUZE WEIGHT) | KDA | 1986-05-23 | 14 |
| K861805 | MEDCARE FORCEPS (THUMB, TISSUE) | GEN | 1986-05-23 | 14 |
| K861804 | MEDCARE SUTURE REMOVAL KIT | — | 1986-05-23 | 14 |
| K860683 | MEDCARE EMERGENCY SHEARS/PUNCH & FIN TIPS | — | 1986-03-13 | 16 |
Recalls
openFDA lists no recalls under a recalling firm named Medcomp Technologies, 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 Medcomp Technologies, Inc. have?
Medcomp Technologies, Inc. has 5 FDA 510(k) clearances (first 1986, latest 1986), across 4 product codes in 1 review panel.
How long does FDA take to clear Medcomp Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Medcomp Technologies, Inc.'s cleared 510(k)s is 14 days.
What devices does Medcomp Technologies, Inc. make?
Its most frequent FDA product codes are GEN (Forceps, General & Plastic Surgery, 1); HRQ (Hemostat, 1); KDA (Prosthesis, Ptfe/Carbon-Fiber, 1).
Has Medcomp Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medcomp Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 5 Medcomp Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEN, Medcomp Technologies, 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.