Medsource International, LLC: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Medsource International, LLC” (first 2008, latest 2023), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 127 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 | 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, 510(k)s cleared under the name Medsource International, LLC 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 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.
- MedSource Labs, LLC (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medsource International, LLC?
FDA lists 10 510(k) clearances under the applicant name “Medsource International, LLC” (first 2008, latest 2023), 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 Medsource International, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medsource International, LLC is 127 days.
Which FDA product codes appear under Medsource International, LLC?
The most frequent FDA product codes under this applicant name 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).
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. 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.