Telemed: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Telemed” (first 2011, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 217 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 | 1 | 90 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 108 |
| 2017 | 1 | 275 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 291 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Telemed took a median 283 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 3 | 3 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
Review panels
- Radiology (5)
Most recent Telemed 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211248 | ArtUs | IYN | 2022-02-11 | 291 |
| K163121 | SmartUs EXT-1M/3M | IYN | 2017-08-10 | 275 |
| K161968 | MicrUs | IYO | 2016-11-03 | 108 |
| K113184 | LOGICSCAN 64 LOGICSCAN 128 | IYN | 2012-01-26 | 90 |
| K102253 | ECHO BLASTER | IYO | 2011-03-14 | 217 |
Recalls
openFDA lists no recalls under a recalling firm named Telemed.
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.
- Telemed Systems, Inc. (22 510(k)s)
- Telemed Div. (2 510(k)s)
- Telemed Solutions, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Telemed?
FDA lists 5 510(k) clearances under the applicant name “Telemed” (first 2011, latest 2022), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Telemed?
The median time from FDA receipt to decision across 510(k)s cleared under the name Telemed is 217 days.
Which FDA product codes appear under Telemed?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 3); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 2).
Next steps
- See all 5 Telemed clearances with predicates and recalls
- Run predicate analysis for product code IYN, Telemed'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.