Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medcomp (Dba Medical Components, Inc.) — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171483 | ArchFlo CT Midline | Medcomp (Dba Medical Components, Inc.) | 2017-12-15 | 207 | 0 |
| K171618 | Symetrex Long Term Hemodialysis Catheter | Medcomp (Dba Medical Components, Inc.) | 2017-11-16 | 167 | 0 |
| K171333 | 20G x 5/8 Pro-Lock CT Safety Infusion Set | Medcomp (Dba Medical Components, Inc.) | 2017-07-18 | 71 | 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