Medex, Inc.: FDA filings under this applicant name
FDA lists 50 510(k) clearances under the applicant name “Medex, Inc.” (first 1977, latest 2025), across 19 product codes in 5 review panels. Median 510(k) review time under this name: 78 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 | 1 | 447 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 272 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medex, Inc. took a median 360 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 175 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 9 | 9 |
| DRS | Transducer, Blood-Pressure, Extravascular | 7 | 7 |
| FRN | Pump, Infusion | 6 | 6 |
| FMG | Stopcock, I.V. Set | 4 | 4 |
| KRA | Catheter, Continuous Flush | 3 | 3 |
| KXO | Monitor, Pressure, Intrauterine | 3 | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| FMF | Syringe, Piston | 2 | 2 |
| FPB | Filter, Infusion Line | 2 | 2 |
| GWM | Device, Monitoring, Intracranial Pressure | 2 | 2 |
Plus 9 more product codes.
Review panels
- General Hospital (25)
- Cardiovascular (19)
- Obstetrics and Gynecology (3)
- Neurology (2)
- Physical Medicine (1)
Most recent Medex, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242255 | Qitexio® 4-Way Stopcock (QIT014) | FMG | 2025-04-29 | 272 |
| K203738 | Qitexio | FMF | 2022-03-14 | 447 |
| K042432 | PHARMGUARD TOOLBOX, MODEL G6000782 | FRN | 2005-01-04 | 118 |
| K040899 | MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP | FRN | 2004-04-30 | 24 |
| K020780 | TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP | GWM | 2002-05-20 | 70 |
| K000328 | MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP | FRN | 2000-05-09 | 97 |
| K982640 | MEDEX 3000 SERIES SYRINGE INFUSION PUMP | FRN | 1999-04-06 | 251 |
| K982123 | CONTRAST CONTROL DEVICE | FPA | 1998-07-21 | 35 |
| K955231 | MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP | FRN | 1996-07-18 | 247 |
| K961404 | MX960 REUSABLE PRESSURE TRANSDUCER | DRS | 1996-06-27 | 77 |
40 earlier clearances. See the full list in Caduvo.
Recalls
11 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2005-11-18.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Medex, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medex, Inc.?
FDA lists 50 510(k) clearances under the applicant name “Medex, Inc.” (first 1977, latest 2025), across 19 product codes in 5 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 Medex, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medex, Inc. is 78 days.
Which FDA product codes appear under Medex, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 9); DRS (Transducer, Blood-Pressure, Extravascular, 7); FRN (Pump, Infusion, 6).
Next steps
- See all 50 Medex, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Medex, Inc.'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.