Electromed Intl., Ltd.: FDA clearances and approvals
Electromed Intl., Ltd. has 23 FDA 510(k) clearances (first 1981, latest 2001), across 7 product codes in 3 review panels. Median 510(k) review time: 53 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 |
|---|---|---|---|
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 8 | 8 |
| DRX | Electrode, Electrocardiograph | 6 | 6 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| IZI | System, X-Ray, Angiographic | 1 | 1 |
| LMD | System, Digital Image Communications, Radiological | 1 | 1 |
Review panels
- Radiology (13)
- Cardiovascular (9)
- Neurology (1)
Most recent Electromed Intl., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003688 | VIEW READING STATION | LLZ | 2001-01-22 | 53 |
| K000474 | VIEW NT | LLZ | 2000-04-19 | 65 |
| K990759 | VIEW COM | LLZ | 1999-04-15 | 38 |
| K974255 | CD-R STATION AND VRS-2000 | LMD | 1998-01-27 | 75 |
| K971176 | VIEW ARCHIVING STATION | IZI | 1997-09-03 | 156 |
| K950694 | COMPACT-X | IZO | 1995-03-31 | 45 |
| K880050 | EDEC 60R | IZO | 1988-02-29 | 54 |
| K875341 | EDEC 60 R/F | IZO | 1988-02-01 | 33 |
| K875342 | EDEC 90C | IZO | 1988-01-29 | 30 |
| K871145 | EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR | IZO | 1987-03-31 | 8 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Electromed Intl., Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances does Electromed Intl., Ltd. have?
Electromed Intl., Ltd. has 23 FDA 510(k) clearances (first 1981, latest 2001), across 7 product codes in 3 review panels.
How long does FDA take to clear Electromed Intl., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Electromed Intl., Ltd.'s cleared 510(k)s is 53 days.
What devices does Electromed Intl., Ltd. make?
Its most frequent FDA product codes are IZO (Generator, High-Voltage, X-Ray, Diagnostic, 8); DRX (Electrode, Electrocardiograph, 6); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 3).
Has Electromed Intl., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Electromed Intl., Ltd. Related entities may recall under other names.
Next steps
- See all 23 Electromed Intl., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IZO, Electromed Intl., Ltd.'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.