Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sharp Electronics Corp. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
191 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880715 | (MB-650) BLOOD PRESSURE MONITOR | Sharp Electronics Corp. | 1988-05-09 | 90 | 0 |
| K875093 | NEW MODEL MB-550 BLOOD PRESSURE MONITOR | Sharp Electronics Corp. | 1988-02-05 | 57 | 0 |
| K863672 | MODEL (MB-700) BLOOD PRESSURE MONITOR | Sharp Electronics Corp. | 1986-11-18 | 76 | 0 |
| K861375 | MODEL MB-500 & MB-600 BLOOD PRESSURE MONITORS | Sharp Electronics Corp. | 1986-08-06 | 191 | 0 |
| K862333 | (MT-27) THERMOMETER AND (M-10PC) PROBE COVERS | Sharp Electronics Corp. | 1986-07-08 | 19 | 0 |
| K852194 | MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET | Sharp Electronics Corp. | 1985-09-27 | 130 | 0 |
| K851664 | MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO | Sharp Electronics Corp. | 1985-07-24 | 92 | 0 |
| K850830 | SHARP DIGITAL BP MONITOR MB-371H | Sharp Electronics Corp. | 1985-06-13 | 127 | 0 |
| K842200 | MD308H DIGITAL/MB351H AUTO-BP MONITOR | Sharp Electronics Corp. | 1984-10-24 | 142 | 0 |
| K842199 | ELEC. DIGITAL THERMOMETER MT-20 & 30 | Sharp Electronics Corp. | 1984-07-18 | 44 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda