Medical Components, Inc. (dba MedComp): FDA clearances and approvals
Medical Components, Inc. (dba MedComp) has 8 FDA 510(k) clearances (first 2017, latest 2023), across 5 product codes in 2 review panels. Median 510(k) review time: 98 days. Since 2017 its median was 98 days, against 157 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 133 |
| 2018 | 3 | 64 |
| 2019 | 1 | 206 |
| 2020 | 2 | 118 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 57 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Medical Components, Inc. (dba MedComp)'s cleared 510(k)s took a median 98 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 157 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NIE | Catheter, Hemodialysis, Triple Lumen, Non-Implanted | 3 | 3 |
| MSD | Catheter, Hemodialysis, Implanted | 2 | 2 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 1 | 1 |
| MPB | Catheter, Hemodialysis, Non-Implanted | 1 | 1 |
| PND | Midline Catheter | 1 | 1 |
Review panels
Most recent Medical Components, Inc. (dba MedComp) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232945 | Trio-CT® Triple Lumen Catheter w/ Curved Extensions | NIE | 2023-11-16 | 57 |
| K202176 | Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes | MSD | 2020-09-03 | 30 |
| K192807 | Duo-Flow Side x Side Double Lumen Catheter | MPB | 2020-04-23 | 205 |
| K183219 | Trio-CT Triple Lumen Catheter | NIE | 2019-06-14 | 206 |
| K181175 | 12F Tri-Flow Triple Lumen Catheter | NIE | 2018-07-05 | 64 |
| K173667 | 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes | MSD | 2018-05-17 | 168 |
| K180567 | C3 Wave System | LJS | 2018-04-12 | 38 |
| K170770 | CT Midline | PND | 2017-07-25 | 133 |
Recalls
openFDA lists no recalls under a recalling firm named Medical Components, Inc. (dba MedComp).
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 Medical Components, Inc. (dba MedComp) have?
Medical Components, Inc. (dba MedComp) has 8 FDA 510(k) clearances (first 2017, latest 2023), across 5 product codes in 2 review panels.
How long does FDA take to clear Medical Components, Inc. (dba MedComp)'s 510(k)s?
The median time from FDA receipt to decision across Medical Components, Inc. (dba MedComp)'s cleared 510(k)s is 98 days. Since 2017: 98 days, versus 157 days for all cleared 510(k)s in the same product codes.
What devices does Medical Components, Inc. (dba MedComp) make?
Its most frequent FDA product codes are NIE (Catheter, Hemodialysis, Triple Lumen, Non-Implanted, 3); MSD (Catheter, Hemodialysis, Implanted, 2); LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 1).
Has Medical Components, Inc. (dba MedComp) had device recalls?
openFDA lists no recalls under a recalling firm name matching Medical Components, Inc. (dba MedComp). Related entities may recall under other names.
Next steps
- See all 8 Medical Components, Inc. (dba MedComp) clearances with predicates and recalls
- Run predicate analysis for product code NIE, Medical Components, Inc. (dba MedComp)'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.