Medix Medical Electronics (U.S.A.), Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Medix Medical Electronics (U.S.A.), Inc.” (first 1981, latest 1986), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 52 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 |
|---|---|---|---|
| FRN | Pump, Infusion | 5 | 5 |
| BZQ | Monitor, Breathing Frequency | 2 | 2 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 1 | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| FLN | Monitor, Electric For Gravity Flow Infusion Systems | 1 | 1 |
Plus 1 more product codes.
Review panels
- General Hospital (7)
- Anesthesiology (6)
Most recent Medix Medical Electronics (U.S.A.), Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861040 | ENTERNAL INFUSER MULTIPUMP 203 | FRN | 1986-06-23 | 97 |
| K861001 | PARENTERAL INFUSER MEDIPUMP 204 | FRN | 1986-06-12 | 86 |
| K853393 | INSULIN PUMP INSUMAT 229 | FRN | 1985-11-18 | 98 |
| K852433 | INFUSAFE 205 CATOLOG NO. 205.000 | FLN | 1985-06-27 | 17 |
| K813562 | SYRINGE DRIVER 209 | FRN | 1982-02-01 | 41 |
| K812041 | VENTI-MONITOR MODEL 101 | CAP | 1981-09-25 | 66 |
| K812039 | SPIROMETER 210/211 | BZG | 1981-09-25 | 66 |
| K812045 | INFANT APNEA MONITOR MODEL 100 | BZQ | 1981-09-24 | 65 |
| K812040 | OXYGEN MONITOR 140/141 | CCL | 1981-09-21 | 62 |
| K812046 | TIDAL VOLUME MONITOR 150 | BZK | 1981-08-07 | 17 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medix Medical Electronics (U.S.A.), Inc..
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 Medix Medical Electronics (U.S.A.), 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)
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 Corp. (6 510(k)s)
- Medix I.C.S.A. (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 Medical Electronics (U.S.A.), Inc.?
FDA lists 14 510(k) clearances under the applicant name “Medix Medical Electronics (U.S.A.), Inc.” (first 1981, latest 1986), across 9 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 Medix Medical Electronics (U.S.A.), Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medix Medical Electronics (U.S.A.), Inc. is 52 days.
Which FDA product codes appear under Medix Medical Electronics (U.S.A.), Inc.?
The most frequent FDA product codes under this applicant name are FRN (Pump, Infusion, 5); BZQ (Monitor, Breathing Frequency, 2); BZG (Spirometer, Diagnostic, 1).
Next steps
- See all 14 Medix Medical Electronics (U.S.A.), Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRN, Medix Medical Electronics (U.S.A.), 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.