Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medcomp ( Medical Components) — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
163 daysmedian FDA review time
289 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162389 | Medcomp Vessel Dilator | Medcomp ( Medical Components) | 2017-06-01 | 279 | 0 |
| K153238 | Dignity Dual Port | Medcomp ( Medical Components) | 2016-03-15 | 127 | 0 |
| K143238 | C3 Wave | Medcomp ( Medical Components) | 2015-04-24 | 163 | 0 |
| K132177 | MEDCOMP GEN III POWER INJECTABLE PORT | Medcomp ( Medical Components) | 2013-12-12 | 150 | 2 |
| K130897 | MEDCOMP VASCU-PICC WITH VALVE | Medcomp ( Medical Components) | 2013-10-22 | 204 | 0 |
| K110424 | DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACH | Medcomp ( Medical Components) | 2011-11-30 | 289 | 0 |
| K093309 | PRO-LINE CT (BASIC TRAY) MODEL MR28036101 | Medcomp ( Medical Components) | 2009-11-24 | 33 | 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