Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Harvard Medical Devices , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
209 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100620 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN | Harvard Medical Devices , Ltd. | 2010-07-02 | 120 | 0 |
| K092558 | WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED | Harvard Medical Devices , Ltd. | 2010-03-17 | 209 | 0 |
| K092557 | DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES | Harvard Medical Devices , Ltd. | 2009-12-17 | 119 | 0 |
| K081159 | HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM- | Harvard Medical Devices , Ltd. | 2008-08-08 | 116 | 0 |
| K081061 | HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-00 | Harvard Medical Devices , Ltd. | 2008-07-18 | 95 | 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