Electromed, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under 2 spellings of the applicant name “Electromed, Inc.” (first 1999, latest 2022), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 73 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 | 1 | 104 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 92 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Electromed, Inc. took a median 92 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 156 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BYI | Percussor, Powered-Electric | 5 | 5 |
| ISD | Exerciser, Measuring | 1 | 1 |
Review panels
- Anesthesiology (5)
- Physical Medicine (1)
Most recent Electromed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222496 | Electromed SmartVest Airway Clearance System | BYI | 2022-11-18 | 92 |
| K132794 | SMARTVEST AIRWAY CLEARANCE SYSTEM | BYI | 2013-12-19 | 104 |
| K053248 | SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL | BYI | 2005-12-01 | 10 |
| K040367 | MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ | BYI | 2004-04-07 | 54 |
| K982889 | MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000 | BYI | 1999-06-01 | 288 |
| K990813 | REHCOR | ISD | 1999-04-12 | 32 |
Recalls
openFDA lists no recalls under a recalling firm named Electromed, 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.
Device clinical trials
An industry sponsor named Electromed, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04271969: Clinical Effectiveness Of High Frequency Chest Wall Oscillation (HFCWO) In A Bronchiectasis Population (Completed, started 2020-02-18)
SEC filings
Electromed, Inc. (ELMD): EDGAR filings, CIK 1488917. An SEC registrant with the same name, matched by name only.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Electromed, Inc. (5)
- Electromed Corp. (1)
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.
- Electromed Intl., Ltd. (23 510(k)s)
- Electromed Imaging, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Electromed, Inc.?
FDA lists 6 510(k) clearances under 2 spellings of the applicant name “Electromed, Inc.” (first 1999, latest 2022), across 2 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 Electromed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Electromed, Inc. is 73 days.
Which FDA product codes appear under Electromed, Inc.?
The most frequent FDA product codes under this applicant name are BYI (Percussor, Powered-Electric, 5); ISD (Exerciser, Measuring, 1).
Next steps
- See all 6 Electromed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BYI, Electromed, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.