Med Telectronics , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Med Telectronics , Ltd.” (first 1977, latest 1977), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 10 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 |
|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | 4 | 4 |
| DXY | Implantable Pacemaker Pulse-Generator | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Med Telectronics , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K770661 | GENERATOR, PULSE, IMPLANTABLE | DXY | 1977-04-26 | 19 |
| K770285 | BALL TIP, MODEL #030-188 | DTB | 1977-02-24 | 10 |
| K770284 | BALL TIP, MODEL #030-185 | DTB | 1977-02-24 | 10 |
| K770283 | WEDGE TIP, SMALL, MODEL #030-194 | DTB | 1977-02-24 | 10 |
| K770282 | WEDGE TIP, SMALL, MODEL #030-191 | DTB | 1977-02-24 | 10 |
Recalls
openFDA lists no recalls under a recalling firm named Med Telectronics , 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Med Telectronics , Ltd. (a text match, not an official crosswalk):
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via DXY)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
Frequently asked questions
How many FDA 510(k) clearances are listed under Med Telectronics , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Med Telectronics , Ltd.” (first 1977, latest 1977), 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 Med Telectronics , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Med Telectronics , Ltd. is 10 days.
Which FDA product codes appear under Med Telectronics , Ltd.?
The most frequent FDA product codes under this applicant name are DTB (Permanent Pacemaker Electrode, 4); DXY (Implantable Pacemaker Pulse-Generator, 1).
Next steps
- See all 5 Med Telectronics , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DTB, Med Telectronics , 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.