Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Qxmedical, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
97 daysmedian FDA review time
247 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200317 | Support Catheter | Qxmedical, LLC | 2020-05-14 | 97 | 0 |
| K183679 | Occlusion Balloon Catheter | Qxmedical, LLC | 2019-04-24 | 117 | 0 |
| K160561 | Boosting Catheter | Qxmedical, LLC | 2016-11-02 | 247 | 0 |
| K123311 | QXMEDICAL ACCESS & SUPPORT CATHETER | Qxmedical, LLC | 2013-01-14 | 81 | 0 |
| K120381 | Q50 PLUS STENT GRAFT BALLOON CATHETER | Qxmedical, LLC | 2012-02-24 | 17 | 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