Medix I.C.S.A.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Medix I.C.S.A.” (first 1993, latest 2011), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 235 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 |
|---|---|---|---|
| LBI | Unit, Neonatal Phototherapy | 3 | 3 |
| FMZ | Incubator, Neonatal | 2 | 2 |
| FMT | Warmer, Infant Radiant | 1 | 1 |
Review panels
- General Hospital (6)
Most recent Medix I.C.S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103735 | MEDILED MINI | LBI | 2011-08-15 | 236 |
| K083179 | MEDILED PHOTOTHERAPY LAMP | LBI | 2009-02-27 | 122 |
| K070291 | MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX | FMZ | 2007-09-21 | 234 |
| K931529 | INFANT WARMER | FMT | 1994-03-11 | 350 |
| K931965 | MEDIX PHOTOTHERAPY LAMP | LBI | 1993-12-09 | 231 |
| K920049 | MEDIX PC-305 NEONATAL INCUBATOR | FMZ | 1993-05-21 | 501 |
Recalls
openFDA lists no recalls under a recalling firm named Medix I.C.S.A..
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.
- Medix Biotech, Inc. (39 510(k)s)
- Medix Medical Electronics (U.S.A.), Inc. (14 510(k)s)
- Medix Corp. (6 510(k)s)
- Medix Biochemica (1 510(k)s)
- Medix of Florida, Inc. (1 510(k)s)
- Medix Pharmaceuticals Americas, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medix I.C.S.A.?
FDA lists 6 510(k) clearances under the applicant name “Medix I.C.S.A.” (first 1993, latest 2011), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medix I.C.S.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medix I.C.S.A. is 235 days.
Which FDA product codes appear under Medix I.C.S.A.?
The most frequent FDA product codes under this applicant name are LBI (Unit, Neonatal Phototherapy, 3); FMZ (Incubator, Neonatal, 2); FMT (Warmer, Infant Radiant, 1).
Next steps
- See all 6 Medix I.C.S.A. clearances with predicates and recalls
- Run predicate analysis for product code LBI, Medix I.C.S.A.'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.