Sharp Electronics Corp.: FDA clearances and approvals
Sharp Electronics Corp. has 10 FDA 510(k) clearances (first 1984, latest 1988), across 3 product codes in 3 review panels. Median 510(k) review time: 91 days.
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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 7 | 7 |
| FLL | Continuous Measurement Thermometer | 2 | 2 |
| LHD | Device, Fertility Diagnostic, Proceptive | 1 | 1 |
Review panels
Most recent Sharp Electronics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880715 | (MB-650) BLOOD PRESSURE MONITOR | DXN | 1988-05-09 | 90 |
| K875093 | NEW MODEL MB-550 BLOOD PRESSURE MONITOR | DXN | 1988-02-05 | 57 |
| K863672 | MODEL (MB-700) BLOOD PRESSURE MONITOR | DXN | 1986-11-18 | 76 |
| K861375 | MODEL MB-500 & MB-600 BLOOD PRESSURE MONITORS | DXN | 1986-08-06 | 191 |
| K862333 | (MT-27) THERMOMETER AND (M-10PC) PROBE COVERS | FLL | 1986-07-08 | 19 |
| K852194 | MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET | LHD | 1985-09-27 | 130 |
| K851664 | MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO | DXN | 1985-07-24 | 92 |
| K850830 | SHARP DIGITAL BP MONITOR MB-371H | DXN | 1985-06-13 | 127 |
| K842200 | MD308H DIGITAL/MB351H AUTO-BP MONITOR | DXN | 1984-10-24 | 142 |
| K842199 | ELEC. DIGITAL THERMOMETER MT-20 & 30 | FLL | 1984-07-18 | 44 |
Recalls
openFDA lists no recalls under a recalling firm named Sharp Electronics Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Sharp Electronics Corp. have?
Sharp Electronics Corp. has 10 FDA 510(k) clearances (first 1984, latest 1988), across 3 product codes in 3 review panels.
How long does FDA take to clear Sharp Electronics Corp.'s 510(k)s?
The median time from FDA receipt to decision across Sharp Electronics Corp.'s cleared 510(k)s is 91 days.
What devices does Sharp Electronics Corp. make?
Its most frequent FDA product codes are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 7); FLL (Continuous Measurement Thermometer, 2); LHD (Device, Fertility Diagnostic, Proceptive, 1).
Has Sharp Electronics Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sharp Electronics Corp. Related entities may recall under other names.
Next steps
- See all 10 Sharp Electronics Corp. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Sharp Electronics Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.