Namic: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Namic” (first 1979, latest 1996), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 38 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| DRS | Transducer, Blood-Pressure, Extravascular | 2 | 2 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| MAV | Syringe, Balloon Inflation | 1 | 1 |
Review panels
- Cardiovascular (7)
- General Hospital (1)
Most recent Namic 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953676 | BREEZE DIGITAL INFLATION DEVICE | MAV | 1996-03-29 | 235 |
| K951722 | PERCEPTOR COMPENSATOR MORSE MANIFOLD | DRS | 1996-03-25 | 346 |
| K921322 | MORSE ANESTHESIA MANIFOLD | FPA | 1993-07-09 | 484 |
| K822100 | HIGH PRESSURE CONTRAST INJECTION LINE | DQO | 1982-08-24 | 39 |
| K813549 | CONTINUOUS FLUSH DEVICE | DRS | 1982-01-12 | 22 |
| K790083 | CATHETER, ARTERIAL LINE | DQY | 1979-01-25 | 13 |
| K790082 | ARTERIAL EXTENSION SET | DQO | 1979-01-25 | 13 |
| K782095 | STOPCOCKS, MANIFOLDS | DTL | 1979-01-23 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Namic.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Namic?
FDA lists 8 510(k) clearances under the applicant name “Namic” (first 1979, latest 1996), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Namic?
The median time from FDA receipt to decision across 510(k)s cleared under the name Namic is 38 days.
Which FDA product codes appear under Namic?
The most frequent FDA product codes under this applicant name are DQO (Catheter, Intravascular, Diagnostic, 2); DRS (Transducer, Blood-Pressure, Extravascular, 2); DQY (Catheter, Percutaneous, 1).
Next steps
- See all 8 Namic clearances with predicates and recalls
- Run predicate analysis for product code DQO, Namic'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.