Vermont Medical, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Vermont Medical, Inc.” (first 1978, latest 2003), across 4 product codes in 4 review panels. Median 510(k) review time under this name: 161 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | 5 | 5 |
| GXY | Electrode, Cutaneous | 2 | 2 |
| BXM | Stimulator, Nerve, Ac-Powered | 1 | 1 |
| FMT | Warmer, Infant Radiant | 1 | 1 |
Review panels
- Cardiovascular (5)
- Neurology (2)
- Anesthesiology (1)
- General Hospital (1)
Most recent Vermont Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030073 | VERMED A10021 RESTING EKG TAB ELECTRODE | DRX | 2003-03-28 | 79 |
| K021537 | MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005 | GXY | 2003-03-03 | 297 |
| K010638 | NEUROPLUS, MODEL A10040, A10041, A10042, A10043 | GXY | 2001-05-03 | 59 |
| K921498 | VER MED A10011 PNS DUAL ELEMENT ELECTRODE | BXM | 1993-06-09 | 435 |
| K915831 | THERMAL PROBE COVER | FMT | 1992-06-08 | 161 |
| K911687 | VER-MED A10020 RESTING EKG ELECTRODE | DRX | 1991-10-10 | 177 |
| K910139 | VER-MED A10014 RESTING EKG ELECTRODE & A10021 | DRX | 1991-08-15 | 213 |
| K905489 | VER-MED A10017 UNIVERSAL ELECTRODE | DRX | 1991-03-21 | 104 |
| K781430 | PREGELLED DISPOSABLE E.K.G. ELECTRODE | DRX | 1978-10-31 | 71 |
Recalls
openFDA lists no recalls under a recalling firm named Vermont Medical, 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.
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.
- Vermont Diamond Instruments (2 510(k)s)
- Vermont Wood Industries, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vermont Medical, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Vermont Medical, Inc.” (first 1978, latest 2003), across 4 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 Vermont Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vermont Medical, Inc. is 161 days.
Which FDA product codes appear under Vermont Medical, Inc.?
The most frequent FDA product codes under this applicant name are DRX (Electrode, Electrocardiograph, 5); GXY (Electrode, Cutaneous, 2); BXM (Stimulator, Nerve, Ac-Powered, 1).
Next steps
- See all 9 Vermont Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRX, Vermont Medical, 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.