3t Medical Systems, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “3t Medical Systems, LLC” (first 2001, latest 2007), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 88 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 |
|---|---|---|---|
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 1 | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| EZL | Catheter, Retention Type, Balloon | 1 | 1 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 1 | 1 |
| MJJ | Cpb Check Valve, Retrograde Flow, In-Line | 1 | 1 |
Review panels
Most recent 3t Medical Systems, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K072697 | 3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES | DTN | 2007-12-20 | 87 |
| K022287 | 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS | EZL | 2002-09-23 | 70 |
| K020768 | 3T VESSEL CANNULAS | DWF | 2002-08-23 | 169 |
| K020365 | 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE | KRI | 2002-05-03 | 88 |
| K001245 | 3T L. V. CONTROL VALVE | MJJ | 2001-08-15 | 484 |
Recalls
openFDA lists no recalls under a recalling firm named 3t Medical Systems, LLC.
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 3t Medical Systems, LLC?
FDA lists 5 510(k) clearances under the applicant name “3t Medical Systems, LLC” (first 2001, latest 2007), across 5 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 3t Medical Systems, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name 3t Medical Systems, LLC is 88 days.
Which FDA product codes appear under 3t Medical Systems, LLC?
The most frequent FDA product codes under this applicant name are DTN (Reservoir, Blood, Cardiopulmonary Bypass, 1); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 1); EZL (Catheter, Retention Type, Balloon, 1).
Next steps
- See all 5 3t Medical Systems, LLC clearances with predicates and recalls
- Run predicate analysis for product code DTN, 3t Medical Systems, 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.