Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medcomp (Medical Components, Inc.) — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
257 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171931 | Celerity ECG Cable Accessory Pack | Medcomp (Medical Components, Inc.) | 2017-10-26 | 120 | 0 |
| K162271 | Pro-Lock CT Safety Infusion Set | Medcomp (Medical Components, Inc.) | 2017-04-26 | 257 | 0 |
| K153246 | PTFE Super Sheath Introducer 2.1 | Medcomp (Medical Components, Inc.) | 2016-02-12 | 95 | 0 |
| K141151 | CT MIDLINE | Medcomp (Medical Components, Inc.) | 2014-07-08 | 64 | 0 |
| K140799 | CELERITY SYSYEM | Medcomp (Medical Components, Inc.) | 2014-06-13 | 74 | 1 |
| K132498 | VALVED TEARAWAY INTRODUCER GENERATION II | Medcomp (Medical Components, Inc.) | 2013-11-25 | 108 | 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