Medcomp ( Medical Components): FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Medcomp ( Medical Components)” (first 2009, latest 2017), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 163 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 | 2 | 177 |
| 2014 | 0 | — |
| 2015 | 1 | 163 |
| 2016 | 1 | 127 |
| 2017 | 1 | 279 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medcomp ( Medical Components) took a median 279 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 97 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 3 | 3 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 3 | 3 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
Review panels
- General Hospital (6)
- Cardiovascular (1)
Most recent Medcomp ( Medical Components) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162389 | Medcomp Vessel Dilator | DRE | 2017-06-01 | 279 |
| K153238 | Dignity Dual Port | LJT | 2016-03-15 | 127 |
| K143238 | C3 Wave | LJS | 2015-04-24 | 163 |
| K132177 | MEDCOMP GEN III POWER INJECTABLE PORT | LJT | 2013-12-12 | 150 |
| K130897 | MEDCOMP VASCU-PICC WITH VALVE | LJS | 2013-10-22 | 204 |
| K110424 | DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL | LJT | 2011-11-30 | 289 |
| K093309 | PRO-LINE CT (BASIC TRAY) MODEL MR28036101 | LJS | 2009-11-24 | 33 |
Recalls
openFDA lists no recalls under a recalling firm named Medcomp ( Medical Components).
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medcomp (40 510(k)s)
- Medcomp (Medical Components, Inc.) (6 510(k)s)
- Medcomp Technologies, Inc. (5 510(k)s)
- Medcomp (Dba Medical Components, Inc.) (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medcomp ( Medical Components)?
FDA lists 7 510(k) clearances under the applicant name “Medcomp ( Medical Components)” (first 2009, latest 2017), across 3 product codes in 2 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 Medcomp ( Medical Components)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medcomp ( Medical Components) is 163 days.
Which FDA product codes appear under Medcomp ( Medical Components)?
The most frequent FDA product codes under this applicant name are LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 3); LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 3); DRE (Dilator, Vessel, For Percutaneous Catheterization, 1).
Next steps
- See all 7 Medcomp ( Medical Components) clearances with predicates and recalls
- Run predicate analysis for product code LJS, Medcomp ( Medical Components)'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.