Medcomp: FDA filings under this applicant name
FDA lists 40 510(k) clearances under the applicant name “Medcomp” (first 1982, latest 2014), across 11 product codes in 3 review panels. Median 510(k) review time under this name: 104 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 | 1 | 232 |
| 2014 | 1 | 395 |
| 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 |
|---|---|---|---|
| MSD | Catheter, Hemodialysis, Implanted | 13 | 13 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 11 | 11 |
| DYB | Introducer, Catheter | 4 | 4 |
| LFJ | Catheter, Subclavian | 3 | 3 |
| DQX | Wire, Guide, Catheter | 2 | 2 |
| NIE | Catheter, Hemodialysis, Triple Lumen, Non-Implanted | 2 | 2 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Medcomp 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130889 | SPLIT CATH RG | MSD | 2014-04-28 | 395 |
| K123292 | T3 | NIE | 2013-06-11 | 232 |
| K102966 | 2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC | LJS | 2010-12-21 | 77 |
| K091954 | MICRO-STICK SET | DYB | 2010-01-08 | 191 |
| K092347 | PRO-PICC CT | LJS | 2009-09-16 | 43 |
| K091953 | PRO-PICC | LJS | 2009-09-16 | 77 |
| K090394 | VALVED TEARWAY INTRODUCER | DYB | 2009-09-01 | 196 |
| K091586 | VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN | LJS | 2009-07-23 | 51 |
| K091466 | 1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50 | LJS | 2009-06-17 | 30 |
| K081775 | THE MEDCOMP .010 VASCULAR GUIDEWIRES | DQX | 2009-03-25 | 275 |
30 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medcomp.
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 ( Medical Components) (13 510(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?
FDA lists 40 510(k) clearances under the applicant name “Medcomp” (first 1982, latest 2014), across 11 product codes in 3 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?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medcomp is 104 days.
Which FDA product codes appear under Medcomp?
The most frequent FDA product codes under this applicant name are MSD (Catheter, Hemodialysis, Implanted, 13); LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 11); DYB (Introducer, Catheter, 4).
Next steps
- See all 40 Medcomp clearances with predicates and recalls
- Run predicate analysis for product code MSD, Medcomp'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.