Medsource International, LLC: FDA clearances and approvals
Medsource International, LLC has 10 FDA 510(k) clearances (first 2008, latest 2023), across 5 product codes in 2 review panels. Median 510(k) review time: 127 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 149 |
| 2013 | 0 | — |
| 2014 | 3 | 60 |
| 2015 | 2 | 107 |
| 2016 | 1 | 127 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 270 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Medsource International, LLC's cleared 510(k)s took a median 270 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 197 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 4 | 4 |
| LHI | Set, I.V. Fluid Transfer | 3 | 3 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| CBP | Valve, Non-Rebreathing | 1 | 1 |
| MMK | Container, Sharps | 1 | 1 |
Review panels
- General Hospital (8)
- Anesthesiology (2)
Most recent Medsource International, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223788 | The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter | FOZ | 2023-09-15 | 270 |
| K161779 | MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter | FOZ | 2016-11-03 | 127 |
| K150611 | MedSource ClearSafe Safety IV Catheter | FOZ | 2015-07-15 | 127 |
| K150333 | MedSource Sharps Dart | MMK | 2015-05-08 | 87 |
| K140442 | MEDSOURCE SELECTABLE IV SET | LHI | 2014-04-22 | 60 |
| K140402 | MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET | LHI | 2014-04-03 | 44 |
| K131555 | MEDSOURCE IV SAFETY CATHETER | FOZ | 2014-01-31 | 247 |
| K120424 | MEDSOURCE IV ADMINSTRATION SET | LHI | 2012-07-11 | 149 |
| K080339 | MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) | BTR | 2008-10-27 | 262 |
| K081516 | MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT | CBP | 2008-08-26 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Medsource International, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Medsource International, LLC have?
Medsource International, LLC has 10 FDA 510(k) clearances (first 2008, latest 2023), across 5 product codes in 2 review panels.
How long does FDA take to clear Medsource International, LLC's 510(k)s?
The median time from FDA receipt to decision across Medsource International, LLC's cleared 510(k)s is 127 days.
What devices does Medsource International, LLC make?
Its most frequent FDA product codes are FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 4); LHI (Set, I.V. Fluid Transfer, 3); BTR (Tube, Tracheal (W/Wo Connector), 1).
Has Medsource International, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Medsource International, LLC. Related entities may recall under other names.
Next steps
- See all 10 Medsource International, LLC clearances with predicates and recalls
- Run predicate analysis for product code FOZ, Medsource International, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.