Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Grandway Technology (Shenzhen) Limited · Predicate Candidate Screening

21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

104 daysmedian FDA review time
334 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K191593Digital Automatic Blood Pressure Monitor MD36 SeriesGrandway Technology (Shenzhen) Limited2019-07-22380
K171379Digital Automatic Wrist Blood Pressure Monitor MD4300Grandway Technology (Shenzhen) Limited2018-04-103340
K163648Digital Automatic Blood Pressure Monitor BPM41 Series, DigitGrandway Technology (Shenzhen) Limited2017-07-071960
K163679Digital Automatic Blood Pressure Monitor MD3600Grandway Technology (Shenzhen) Limited2017-06-071620
K163113Digital Automatic Wrist Blood Pressure Monitor SWBPM22 SerieGrandway Technology (Shenzhen) Limited2017-01-19730
K152483Digital Automatic Blood Pressure Monitor BPM30 and BPM31 SerGrandway Technology (Shenzhen) Limited2015-09-29290
K151587Digital Automatic Wrist Blood Pressure Monitor MD3200Grandway Technology (Shenzhen) Limited2015-08-07570
K151583Digital Automatic Wrist Blood Pressure Monitor MD3900Grandway Technology (Shenzhen) Limited2015-08-07570
K143735Digital Automatic Blood Pressure Monitor MD2300Grandway Technology (Shenzhen) Limited2015-07-232050
K150373Digital Automatic Blood Pressure Monitor BPM25 & BPM26 SerieGrandway Technology (Shenzhen) Limited2015-06-111180
K143734Digital Automatic Blood Pressure Monitor BPM28 Series - MD28Grandway Technology (Shenzhen) Limited2015-05-021230
K143733Digital Automatic Wrist Blood Pressure Monitor MD2400Grandway Technology (Shenzhen) Limited2015-04-03940
K142088DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIEGrandway Technology (Shenzhen) Limited2014-10-31910
K140583DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM20 SERIESGrandway Technology (Shenzhen) Limited2014-06-181040
K133619DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIESGrandway Technology (Shenzhen) Limited2014-03-051000
K133618DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIESGrandway Technology (Shenzhen) Limited2014-03-051000
K132240DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIESGrandway Technology (Shenzhen) Limited2013-12-161510
K123073DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL Grandway Technology (Shenzhen) Limited2013-03-111610
K120675DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIESGrandway Technology (Shenzhen) Limited2013-02-143460
K120673DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIESGrandway Technology (Shenzhen) Limited2013-02-143460
K110299DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM10 SERIESGrandway Technology (Shenzhen) Limited2011-03-21480

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