Medix Corp.: FDA clearances and approvals
Medix Corp. has 6 FDA 510(k) clearances (first 1978, latest 2004), across 5 product codes in 3 review panels. Median 510(k) review time: 63 days.
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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 2 | 2 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
Review panels
- Anesthesiology (3)
- General Hospital (2)
- Neurology (1)
Most recent Medix Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041345 | PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES | FOZ | 2004-07-22 | 63 |
| K921273 | EASIMIST ULTRASONIC NEBULIZER | CAF | 1994-04-01 | 745 |
| K914772 | MEDIX NEBULIZING SYSTEM CODE NO. 2000 AND 2001 | CAF | 1992-07-24 | 312 |
| K853071 | MEDIX ELECTRONIC NEBULIZING SYSTEM | CCQ | 1985-08-29 | 37 |
| K822454 | SYRINGE PUMP 209-100 | FRN | 1982-10-18 | 63 |
| K780444 | NERVTRON-RX | GZJ | 1978-04-19 | 30 |
Recalls
openFDA lists no recalls under a recalling firm named Medix Corp..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Medix Corp.'s product codes (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)
- G0379 — Direct admission of patient for hospital observation care (via CAF)
Frequently asked questions
How many FDA 510(k) clearances does Medix Corp. have?
Medix Corp. has 6 FDA 510(k) clearances (first 1978, latest 2004), across 5 product codes in 3 review panels.
How long does FDA take to clear Medix Corp.'s 510(k)s?
The median time from FDA receipt to decision across Medix Corp.'s cleared 510(k)s is 63 days.
What devices does Medix Corp. make?
Its most frequent FDA product codes are CAF (Nebulizer (Direct Patient Interface), 2); CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer), 1); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 1).
Has Medix Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medix Corp. Related entities may recall under other names.
Next steps
- See all 6 Medix Corp. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Medix Corp.'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.