Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Navilyst Medical, Inc. · Predicate Candidate Screening
35 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
232 days90th percentile
35clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163452 | PICC Maximal Barrier Nursing Kit | Navilyst Medical, Inc. | 2017-02-03 | 56 | 0 |
| K161866 | BioFlo Midline Catheter | Navilyst Medical, Inc. | 2016-09-08 | 63 | 0 |
| K151239 | NMI DUAL PORT II | Navilyst Medical, Inc. | 2016-06-06 | 392 | 0 |
| K153228 | NMI Port, NMI Port II | Navilyst Medical, Inc. | 2015-12-04 | 28 | 0 |
| K152069 | Exodus Array Multipurpose Drainage Catheter, Exodus Nuance N | Navilyst Medical, Inc. | 2015-09-24 | 59 | 0 |
| K152409 | Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Pow | Navilyst Medical, Inc. | 2015-09-24 | 29 | 0 |
| K150407 | BioFlo Midline Catheter | Navilyst Medical, Inc. | 2015-05-15 | 86 | 0 |
| K150527 | Xcela Power Injectable PICC | Navilyst Medical, Inc. | 2015-03-31 | 29 | 0 |
| K150448 | NMI PICC III and NMI PICC IV | Navilyst Medical, Inc. | 2015-03-19 | 27 | 0 |
| K142616 | PICC Maximal Barrier Nursing Kit | Navilyst Medical, Inc. | 2014-10-14 | 28 | 0 |
| K140194 | NAMIC RCS SYRINGE | Navilyst Medical, Inc. | 2014-04-14 | 77 | 0 |
| K140266 | NMI PICC IV | Navilyst Medical, Inc. | 2014-03-05 | 30 | 0 |
| K131260 | NMI DIALYSIS CATHETER | Navilyst Medical, Inc. | 2014-02-14 | 288 | 2 |
| K133264 | NMI PICC III | Navilyst Medical, Inc. | 2013-11-20 | 28 | 0 |
| K132713 | NMI COAXIAL MICROINTRODUCER SET | Navilyst Medical, Inc. | 2013-09-27 | 28 | 15 |
| K131694 | NMI PORT II CATHETER | Navilyst Medical, Inc. | 2013-08-08 | 59 | 1 |
| K131942 | NMI PICC III CATHETER, NMI HPICC III CATHETER | Navilyst Medical, Inc. | 2013-07-31 | 34 | 0 |
| K131038 | NMI PICC MAXIMAL BARRIER NURSING KITS | Navilyst Medical, Inc. | 2013-05-09 | 24 | 12 |
| K122767 | NMI PORT | Navilyst Medical, Inc. | 2013-04-30 | 232 | 1 |
| K123445 | NMI COAXIAL MICROINTRODUCER SET | Navilyst Medical, Inc. | 2013-04-01 | 144 | 0 |
| K122882 | NMI HPICC III | Navilyst Medical, Inc. | 2012-10-18 | 28 | 0 |
| K121089 | NMI PICC III | Navilyst Medical, Inc. | 2012-08-23 | 135 | 0 |
| K121990 | PICC CONVENIENCE KIT | Navilyst Medical, Inc. | 2012-08-03 | 28 | 12 |
| K121954 | NMI MICROCATHETER | Navilyst Medical, Inc. | 2012-07-17 | 14 | 0 |
| K113638 | NMI 2.8 MICROCATHETER | Navilyst Medical, Inc. | 2012-01-05 | 27 | 0 |
| K113198 | NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML | Navilyst Medical, Inc. | 2011-11-28 | 28 | 1 |
| K112124 | MICROCATHETER | Navilyst Medical, Inc. | 2011-08-19 | 25 | 0 |
| K111906 | XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY | Navilyst Medical, Inc. | 2011-07-29 | 24 | 0 |
| K111315 | MULTIPURPOSE DRAINAGE CATHETER | Navilyst Medical, Inc. | 2011-06-08 | 29 | 0 |
| K103353 | MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETE | Navilyst Medical, Inc. | 2011-01-14 | 59 | 0 |
| K101326 | NMI IC | Navilyst Medical, Inc. | 2010-09-02 | 114 | 0 |
| K091634 | NMI FC | Navilyst Medical, Inc. | 2010-03-01 | 270 | 0 |
| K093392 | MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS | Navilyst Medical, Inc. | 2009-12-31 | 62 | 3 |
| K093366 | NMI PICC II | Navilyst Medical, Inc. | 2009-11-24 | 26 | 0 |
| K091261 | NMI PICC | Navilyst Medical, Inc. | 2009-05-12 | 13 | 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