Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Marvao Medical Devices, Ltd. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
259 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220632 | Boss Crossing Support Catheter | Marvao Medical Devices, Ltd. | 2022-06-02 | 90 | 0 |
| K173805 | NexSite HD Hemodialysis Symmetric Tip Catheter for long term | Marvao Medical Devices, Ltd. | 2018-02-08 | 55 | 0 |
| K171571 | NexSite HD, Hemodialysis Step Tip Catheter (60cm) | Marvao Medical Devices, Ltd. | 2017-11-30 | 184 | 0 |
| K161026 | NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use | Marvao Medical Devices, Ltd. | 2016-08-09 | 119 | 0 |
| K143567 | NexSite HD Hemodialysis Split Tip Catheter for long term use | Marvao Medical Devices, Ltd. | 2015-03-31 | 105 | 0 |
| K140492 | NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE | Marvao Medical Devices, Ltd. | 2014-11-13 | 259 | 0 |
| K133796 | NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), | Marvao Medical Devices, Ltd. | 2014-01-31 | 49 | 0 |
| K121933 | NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NE | Marvao Medical Devices, Ltd. | 2013-03-14 | 255 | 0 |
| K110627 | NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER | Marvao Medical Devices, Ltd. | 2011-08-12 | 161 | 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