NuMED, Inc.: FDA filings under this applicant name
FDA lists 48 510(k) clearances under the applicant name “NuMED, Inc.” (first 1985, latest 2022), plus 1 PMA and 1 De Novo decisions, across 14 product codes in 1 review panel. Median 510(k) review time under this name: 51 days. Since 2017 the median was 29 days, against 91 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 76 |
| 2013 | 1 | 45 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 3 | 110 |
| 2017 | 1 | 178 |
| 2018 | 0 | — |
| 2019 | 1 | 29 |
| 2020 | 0 | — |
| 2021 | 2 | 34 |
| 2022 | 1 | 28 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name NuMED, Inc. took a median 29 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 12 | 12 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 7 | 7 |
| DQO | Catheter, Intravascular, Diagnostic | 5 | 5 |
| MJN | Catheter, Intravascular Occluding, Temporary | 5 | 5 |
| NVM | Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon | 5 | 5 |
| DXF | Catheter, Septostomy | 3 | 3 |
| LDF | Electrode, Pacemaker, Temporary | 3 | 3 |
| DYB | Introducer, Catheter | 2 | 2 |
| OMZ | Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter | 2 | 2 |
| OZT | Balloon Aortic Valvuloplasty | 2 | 1 |
Plus 4 more product codes.
Review panels
- Cardiovascular (50)
Most recent NuMED, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213915 | BIB Stent Placement Catheter | NVM | 2022-01-12 | 28 |
| K211910 | Z-6 Atrioseptostomy Catheter | DXF | 2021-07-19 | 28 |
| K211134 | BIB Stent Placement Catheter | NVM | 2021-05-27 | 41 |
| K190974 | D'Vill Introducer | DYB | 2019-05-14 | 29 |
| K171206 | D'Vill Introducer | DYB | 2017-10-20 | 178 |
| K161451 | BIB Stent Placement Catheter | NVM | 2016-09-22 | 119 |
| K160598 | REBOA Balloon Catheter | MJN | 2016-06-20 | 110 |
| K160889 | BIB Stent Placement Catheter | NVM | 2016-05-20 | 50 |
| K131869 | PTS-X SIZING BALLOON CATHETER | MJN | 2013-08-08 | 45 |
| K122012 | Z-MED Z-MED II | OZT | 2012-10-04 | 86 |
38 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P150028 | PMA | CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent) | 2016-03-25 |
| DEN080015 | De Novo | Balloon Aortic Valvuloplasty | 2012-06-11 |
Recalls
5 product recalls in 4 recall events; 1 initiated in the last five years. Most recent: 2025-04-21.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Numed Technologies, Inc. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under NuMED, Inc.?
FDA lists 48 510(k) clearances under the applicant name “NuMED, Inc.” (first 1985, latest 2022), plus 1 PMA and 1 De Novo decisions, across 14 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by NuMED, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name NuMED, Inc. is 51 days. Since 2017: 29 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under NuMED, Inc.?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 12); LIT (Catheter, Angioplasty, Peripheral, Transluminal, 7); DQO (Catheter, Intravascular, Diagnostic, 5).
Next steps
- See all 48 NuMED, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQY, NuMED, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.