Medcor, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Medcor, Inc.” (first 1977, latest 1980), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 16 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 |
|---|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | 6 | 6 |
Plus 1 more product codes.
Review panels
- Cardiovascular (6)
Most recent Medcor, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K792609 | LITHICRON 0520 P-SYNCHRONEOUS PULSE GEN. | DXY | 1980-11-19 | 337 |
| K802224 | QUINTREX 0516 PROG. PULSE GENERATOR SYS | — | 1980-09-12 | 0 |
| K802223 | QUINTREX 0515 PROGRAMMABLE PULSE GEN. | — | 1980-09-12 | 0 |
| K791678 | LITHICRON II 0403 IMPLANTABLE PACEMAKER | DXY | 1979-09-07 | 10 |
| K791095 | LITHICRON MODEL 0401, PACEMAKER | DXY | 1979-08-10 | 59 |
| K780430 | LITHICRON F PROGRAMMABLE PULSE GEN | DXY | 1978-12-22 | 280 |
| K771538 | LITHICRON MODEL 3-70C-B PULSE GENERATOR | DXY | 1977-08-22 | 11 |
| K770507 | PULSE GENERATOR, LITKICRON MODEL 3-70H | DXY | 1977-04-07 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Medcor, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Medcor, Inc. (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 Medcor, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Medcor, Inc.” (first 1977, latest 1980), 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 Medcor, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medcor, Inc. is 16 days.
Which FDA product codes appear under Medcor, Inc.?
The most frequent FDA product codes under this applicant name are DXY (Implantable Pacemaker Pulse-Generator, 6).
Next steps
- See all 8 Medcor, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXY, Medcor, 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.