Levitronix, LLC: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Levitronix, LLC” (first 2003, latest 2011), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 50 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 |
|---|---|---|---|
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | 6 | 6 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 3 | 3 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 | 2 |
Review panels
- Cardiovascular (11)
Most recent Levitronix, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110983 | CENTRIMAG DRAINAGE CANNULA KIT | DWF | 2011-06-20 | 74 |
| K110980 | CENTRIMAG RETURN CANNULA KIT | DWF | 2011-06-20 | 74 |
| K102129 | LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR | DWA | 2010-08-27 | 29 |
| K093832 | LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES | DWA | 2010-01-13 | 30 |
| K090051 | LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 | KFM | 2009-10-08 | 274 |
| K090004 | LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES | DWA | 2009-01-15 | 13 |
| K083340 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE | DWA | 2008-11-26 | 14 |
| K081221 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE | DWA | 2008-06-19 | 50 |
| K053630 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE | DWA | 2006-01-26 | 28 |
| K051209 | LEVITRONIX CENTRIMAG BACK-UP CONSOLE | KFM | 2005-09-08 | 120 |
1 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2008-03-17.
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 Levitronix, LLC?
FDA lists 11 510(k) clearances under the applicant name “Levitronix, LLC” (first 2003, latest 2011), across 3 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 Levitronix, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Levitronix, LLC is 50 days.
Which FDA product codes appear under Levitronix, LLC?
The most frequent FDA product codes under this applicant name are DWA (Control, Pump Speed, Cardiopulmonary Bypass, 6); KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type, 3); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 2).
Next steps
- See all 11 Levitronix, LLC clearances with predicates and recalls
- Run predicate analysis for product code DWA, Levitronix, LLC'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.