Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Components, Inc. (dba MedComp) — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
133 daysmedian FDA review time
251 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232945 | Trio-CT® Triple Lumen Catheter w/ Curved Extensions | Medical Components, Inc. (dba MedComp) | 2023-11-16 | 57 | 0 |
| K202176 | Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sidehole | Medical Components, Inc. (dba MedComp) | 2020-09-03 | 30 | 0 |
| K192807 | Duo-Flow Side x Side Double Lumen Catheter | Medical Components, Inc. (dba MedComp) | 2020-04-23 | 205 | 0 |
| K183219 | Trio-CT Triple Lumen Catheter | Medical Components, Inc. (dba MedComp) | 2019-06-14 | 206 | 0 |
| K181175 | 12F Tri-Flow Triple Lumen Catheter | Medical Components, Inc. (dba MedComp) | 2018-07-05 | 64 | 0 |
| K173667 | 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with | Medical Components, Inc. (dba MedComp) | 2018-05-17 | 168 | 0 |
| K180567 | C3 Wave System | Medical Components, Inc. (dba MedComp) | 2018-04-12 | 38 | 0 |
| K170934 | C3 Wave System | Medical Components, Inc (Dba Medcomp_ | 2017-12-06 | 251 | 0 |
| K170770 | CT Midline | Medical Components, Inc. (dba MedComp) | 2017-07-25 | 133 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda