Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NuMED, Inc. — Predicate Candidate Screening
49 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
52 daysmedian FDA review time
210 days90th percentile
49clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213915 | BIB Stent Placement Catheter | NuMED, Inc. | 2022-01-12 | 28 | 0 |
| K211910 | Z-6 Atrioseptostomy Catheter | NuMED, Inc. | 2021-07-19 | 28 | 0 |
| K211134 | BIB Stent Placement Catheter | NuMED, Inc. | 2021-05-27 | 41 | 0 |
| K190974 | D'Vill Introducer | NuMED, Inc. | 2019-05-14 | 29 | 0 |
| K171206 | D'Vill Introducer | NuMED, Inc. | 2017-10-20 | 178 | 0 |
| K161451 | BIB Stent Placement Catheter | NuMED, Inc. | 2016-09-22 | 119 | 0 |
| K160598 | REBOA Balloon Catheter | NuMED, Inc. | 2016-06-20 | 110 | 0 |
| K160889 | BIB Stent Placement Catheter | NuMED, Inc. | 2016-05-20 | 50 | 0 |
| K131869 | PTS-X SIZING BALLOON CATHETER | NuMED, Inc. | 2013-08-08 | 45 | 0 |
| K122012 | Z-MED Z-MED II | NuMED, Inc. | 2012-10-04 | 86 | 0 |
| K121859 | TYSHAK NUCLEUS | NuMED, Inc. | 2012-08-31 | 66 | 0 |
| DEN080015 | NUCLEUS-X PTV CATHETER | NuMED, Inc. | 2012-06-11 | 1265 | 0 |
| K110903 | PTS-X SIZING BALLOON CATHETER | NuMED, Inc. | 2011-04-29 | 29 | 0 |
| K102473 | MULLINS-X PTV CATHETER | NuMED, Inc. | 2010-12-09 | 101 | 0 |
| K082868 | MULLINS-X, MODEL 250X | NuMED, Inc. | 2008-10-24 | 25 | 0 |
| K082524 | MINI GHOST, MODEL: 507 | NuMED, Inc. | 2008-09-26 | 24 | 0 |
| K081680 | NUCLEUS-X, MODEL 230X | NuMED, Inc. | 2008-07-10 | 23 | 0 |
| K050857 | BIB PTA BALLOON CATHETER | NuMED, Inc. | 2005-07-28 | 114 | 1 |
| K051343 | MINI GHOST PTA CATHETER, MODEL 507 | NuMED, Inc. | 2005-07-28 | 66 | 0 |
| K040830 | PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS | NuMED, Inc. | 2004-06-18 | 79 | 0 |
| K041306 | NUMED PTS X SIZING BALLOON CATHETER | NuMED, Inc. | 2004-06-10 | 24 | 0 |
| K041093 | NUMED MULLINS X PTA CATHETER | NuMED, Inc. | 2004-05-06 | 9 | 0 |
| K032591 | NUMED TYSHAK MINI PEDIATRIC PTV CATHETER | NuMED, Inc. | 2003-09-25 | 34 | 0 |
| K030589 | MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS | NuMED, Inc. | 2003-05-21 | 85 | 0 |
| K022722 | PTA AND PTV | NuMED, Inc. | 2002-09-13 | 28 | 0 |
| K014124 | NUMED COEFFICIENT PTV CATHETERS | NuMED, Inc. | 2002-01-16 | 30 | 0 |
| K013601 | NUMED MULLINS PTA CATHETER | NuMED, Inc. | 2002-01-03 | 64 | 0 |
| K011557 | PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS | NuMED, Inc. | 2001-07-12 | 52 | 0 |
| K003320 | PTA-OS SIZING BALLOON, MODEL 360 | NuMED, Inc. | 2001-05-02 | 190 | 0 |
| K010880 | NUMED HIGH PRESSURE PTA CATHETERS | NuMED, Inc. | 2001-04-20 | 28 | 0 |
| K003902 | MULTITRACK ANGIOGRAPHIC CATHETER | NuMED, Inc. | 2001-01-11 | 23 | 0 |
| K003972 | NUMED GHOST II PTA CATHETERS | NuMED, Inc. | 2001-01-11 | 20 | 0 |
| K003643 | NUMED Z-MED PTV CATHERERS | NuMED, Inc. | 2000-12-27 | 30 | 0 |
| K003276 | TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107 | NuMED, Inc. | 2000-12-01 | 43 | 0 |
| K003114 | NUMED TYSHAK AND Z-MED PTV CATHETERS | NuMED, Inc. | 2000-11-01 | 27 | 0 |
| K003052 | NUMED TYSHAK II AND Z-MED II PTV CATHETERS | NuMED, Inc. | 2000-11-01 | 30 | 0 |
| K991977 | TYSHAK, MODEL 102 AND Z-MED, MODEL 302 | NuMED, Inc. | 2000-09-27 | 474 | 0 |
| K001804 | NUMED Z-5 ATRIOSEPTOSTOMY CATHETER | NuMED, Inc. | 2000-07-12 | 27 | 0 |
| K960070 | NUMED ATRIOSEPTOSTOMY CATHETER | NuMED, Inc. | 1996-04-02 | 88 | 0 |
| K931009 | TYSHAK PERIPHERAL BALLOON DILATION CATHETER | NuMED, Inc. | 1993-12-21 | 305 | 1 |
| K883948 | MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER | NuMED, Inc. | 1989-04-21 | 220 | 0 |
| K881893 | NUMED BALLOON THERMODILUTION CATHETER | NuMED, Inc. | 1988-09-06 | 124 | 0 |
| K871796 | NUMED PTA CATHETERS | NuMED, Inc. | 1987-12-03 | 210 | 0 |
| K864943 | NUMED BALLOON WEDGE PRESSURE CATHETER | NuMED, Inc. | 1987-02-20 | 65 | 0 |
| K864940 | NUMED BALLOON ANGIOGRAPHIC CATHETERS | NuMED, Inc. | 1987-02-19 | 64 | 0 |
| K860121 | INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER | NuMED, Inc. | 1986-06-02 | 140 | 0 |
| K851845 | NUMED TEMP. STYLET PACING PAROBE 1318694 | NuMED, Inc. | 1985-08-29 | 125 | 0 |
| K851246 | NUMED BALLOON PACING CATHETER | NuMED, Inc. | 1985-04-19 | 25 | 0 |
| K843290 | NUMED BALLOON PACING CATHETER | NuMED, Inc. | 1985-01-14 | 146 | 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