Carolina Medical Electronics: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Carolina Medical Electronics” (first 1977, latest 1991), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 49 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 3 | 3 |
| DPW | Flowmeter, Blood, Cardiovascular | 2 | 2 |
| DSB | Plethysmograph, Impedance | 1 | 1 |
| DWJ | System, Thermal Regulating | 1 | 1 |
| DXK | Echocardiograph | 1 | 1 |
| DXY | Implantable Pacemaker Pulse-Generator | 1 | 1 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (6)
- Radiology (4)
Most recent Carolina Medical Electronics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K914200 | VASCUMAP MEDICAL AIR PLETHYSMOGRAPH | DSB | 1991-11-07 | 49 |
| K874685 | TRANS-SCAN 3-D TRANSCRANIAL DOPPLER | IYO | 1988-04-25 | 165 |
| K874684 | TC2-64B TRANSCRANIAL DOPPLER | IYO | 1988-04-25 | 165 |
| K864624 | PROBE, UPTAKE, NUCLEAR | IZO | 1987-08-10 | 258 |
| K843891 | DOPSCAN PLUS DS1060 | IYO | 1985-01-09 | 99 |
| K837329 | SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND | — | 1983-06-07 | 91 |
| K820272 | CLINIFLOW II, #701, ELECTROMAGN. BLD. SY | DPW | 1982-03-12 | 38 |
| K810561 | DOPSCAN MODEL 1050 | DPW | 1981-04-10 | 38 |
| K801647 | SONACOLOR 6100 | DXY | 1980-08-20 | 33 |
| K792540 | SONACOLOR 6000 | DXK | 1980-01-17 | 38 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Carolina Medical Electronics.
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 Carolina Medical Electronics (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)
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.
- Carolina Liquid Chemistries Corp. (21 510(k)s)
- Carolina Medical, Inc. (2 510(k)s)
- Carolina Narrow Fabric Co. (2 510(k)s)
- Carolina Biological Supply Co. (1 510(k)s)
- Carolina Medical Products Co. (1 510(k)s)
- Carolina X-Ray Co., Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Carolina Medical Electronics?
FDA lists 11 510(k) clearances under the applicant name “Carolina Medical Electronics” (first 1977, latest 1991), across 8 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 Carolina Medical Electronics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Carolina Medical Electronics is 49 days.
Which FDA product codes appear under Carolina Medical Electronics?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 3); DPW (Flowmeter, Blood, Cardiovascular, 2); DSB (Plethysmograph, Impedance, 1).
Next steps
- See all 11 Carolina Medical Electronics clearances with predicates and recalls
- Run predicate analysis for product code IYO, Carolina Medical Electronics'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.