Atlas FDA

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

Joytech Healthcare Co. , Ltd. · Predicate Candidate Screening

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

177 daysmedian FDA review time
278 days90th percentile
22clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252501Arm-type Fully Automatic Digital Blood Pressure Monitor (DBPJoytech Healthcare Co. , Ltd.2026-04-282630
K252685Arm-type Fully Automatic Digital Blood Pressure Monitor (DBPJoytech Healthcare Co. , Ltd.2026-02-131710
K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-110Joytech Healthcare Co. , Ltd.2025-07-022360
K250548Arm-type Fully Automatic Digital Blood Pressure Monitors (DBJoytech Healthcare Co. , Ltd.2025-06-261210
K241431Arm-type Fully Automatic Digital Blood Pressure Monitor (DBPJoytech Healthcare Co. , Ltd.2025-01-132370
K241322Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, Joytech Healthcare Co. , Ltd.2024-12-192230
K231303Arm-type Fully Automatic Digital Blood Pressure MonitorJoytech Healthcare Co. , Ltd.2024-01-262660
K230566Arm-type Fully Automatic Digital Blood Pressure Monitor, WriJoytech Healthcare Co. , Ltd.2023-08-251770
K213189Wrist-type Fully Automatic Digital Blood Pressure MonitorJoytech Healthcare Co. , Ltd.2022-03-011530
K212115Arm-type Fully Automatic Digital Blood Pressure Monitor, WriJoytech Healthcare Co. , Ltd.2022-01-051820
K200649Arm-Type Fully Automatic Digital Blood Pressure MonitorJoytech Healthcare Co. , Ltd.2020-08-031440
K200599Digital ThermometerJoytech Healthcare Co. , Ltd.2020-07-081210
K183393Digital ThermometerJoytech Healthcare Co. , Ltd.2019-11-183460
K190886Non-invasive blood pressure measurement systemsJoytech Healthcare Co. , Ltd.2019-07-291160
K190873Infrared Ear/Forehead ThermometerJoytech Healthcare Co. , Ltd.2019-07-261140
K182629Digital ThermometerJoytech Healthcare Co. , Ltd.2019-02-281570
K181239Infrared Forehead Thermometer, Infrared Ear/Forehead ThermomJoytech Healthcare Co. , Ltd.2018-10-291720
K181081Infrared Ear ThermometerJoytech Healthcare Co. , Ltd.2018-10-021610
K173024Non-invasive blood pressure measurement systemsJoytech Healthcare Co. , Ltd.2018-08-223280
K172989Electric Breast PumpJoytech Healthcare Co. , Ltd.2017-12-20840
K170666The Wrist-Type Fully Automatic Digital Blood Pressure MonitoJoytech Healthcare Co. , Ltd.2017-11-222610
K163518Digital ThermometerJoytech Healthcare Co. , Ltd.2017-09-192780

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