Medicor USA , Ltd.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Medicor USA , Ltd.” (first 1978, latest 1986), across 10 product codes in 4 review panels. Median 510(k) review time under this name: 64 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 |
|---|---|---|---|
| FRF | Cleaner, Air, Medical Recirculating | 2 | 2 |
| IXR | Table, Radiographic, Tilting | 2 | 2 |
| IYB | Tube Mount, X-Ray, Diagnostic | 2 | 2 |
| KPR | System, X-Ray, Stationary | 2 | 2 |
| BZL | Computer, Oxygen-Uptake | 1 | 1 |
| BZN | Cart, Emergency, Cardiopulmonary (Excluding Equipment) | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 1 | 1 |
| LCH | Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (7)
- Anesthesiology (2)
- Clinical Chemistry (2)
- General Hospital (2)
Most recent Medicor USA , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861994 | MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM | KPR | 1986-07-18 | 56 |
| K861995 | MODEL RS-3 RADIOGRAPHIC STAND | IYB | 1986-06-19 | 27 |
| K860025 | MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR | KPR | 1986-05-07 | 124 |
| K850761 | MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C | BZN | 1985-09-19 | 206 |
| K851358 | MODEL BION 2/TYPE 90 ROOM IONIZER | FRF | 1985-07-01 | 88 |
| K851094 | MODEL BION 1/TYPE 1084T CAR IONIZER | FRF | 1985-06-19 | 92 |
| K843335 | FLOOR MOUNTED X-RAY TUBESTAND | IYB | 1984-11-27 | 92 |
| K840227 | UROLIX-3 UROLOGICAL TABLE | IXR | 1984-03-23 | 64 |
| K840225 | C-ARM CEILING CRANE FT-2 | JAA | 1984-03-22 | 63 |
| K840226 | MOTOR TILTED EXAM. TABLE UV-56 | IXR | 1984-03-16 | 57 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medicor USA , Ltd..
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.
- Medicor Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medicor USA , Ltd.?
FDA lists 14 510(k) clearances under the applicant name “Medicor USA , Ltd.” (first 1978, latest 1986), across 10 product codes in 4 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 Medicor USA , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medicor USA , Ltd. is 64 days.
Which FDA product codes appear under Medicor USA , Ltd.?
The most frequent FDA product codes under this applicant name are FRF (Cleaner, Air, Medical Recirculating, 2); IXR (Table, Radiographic, Tilting, 2); IYB (Tube Mount, X-Ray, Diagnostic, 2).
Next steps
- See all 14 Medicor USA , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FRF, Medicor USA , Ltd.'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.