A&D Medical TM-2657 Family of Digital Blood Pressure Monitors
K-Number: K151953 · 2016-04-13
ApplicantA&D Company, Ltd.
Decision Date2016-04-13
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
A&D Medical TM-2657 Family of Digital Blood Pressure Monitors is a medical device manufactured by A&D Company, Ltd.. It received FDA 510(k) clearance on 2016-04-13 under approval number K151953. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the A&D Medical TM-2657 Family of Digital Blood Pressure Monitors?
A&D Medical TM-2657 Family of Digital Blood Pressure Monitors is a medical device that received FDA 510(k) clearance on 2016-04-13. It is manufactured by A&D Company, Ltd.. The 510(k) number is K151953.
When was A&D Medical TM-2657 Family of Digital Blood Pressure Monitors approved by the FDA?
A&D Medical TM-2657 Family of Digital Blood Pressure Monitors received FDA 510(k) clearance on 2016-04-13, under approval number K151953.
What company makes A&D Medical TM-2657 Family of Digital Blood Pressure Monitors?
A&D Medical TM-2657 Family of Digital Blood Pressure Monitors is manufactured by A&D Company, Ltd..
What is the FDA product code for A&D Medical TM-2657 Family of Digital Blood Pressure Monitors?
The FDA product code for A&D Medical TM-2657 Family of Digital Blood Pressure Monitors is DXN.
Related Clinical Trials
NCT01143558
Searching for Persistence of Infection in Lyme Disease
COMPLETED
NCT07260890
Paired Comparison of SVV and PVI Accuracy
COMPLETED
NCT07613762
High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac Rehabilitation.
NOT_YET_RECRUITING
NCT07235592
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
RECRUITING
NCT06090669
Imatinib to Increase RUNX1 Activity in Participants With Germline RUNX1 Deficiency
RECRUITING
NCT01174108
Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells
RECRUITING
Related PubMed Literature
PMID: 42204020
A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows.
Journal of imaging informatics in medicine (2026)
PMID: 42174919
Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data.
Studies in health technology and informatics (2026)
PMID: 42067025
Regulating cybersecurity in digital health: A comparative policy analysis of the USA, EU, and India.
Annales pharmaceutiques francaises (2026)
PMID: 42037982
Ethical, legal, and social implications of AI-enabled digital therapeutics: A comparative analysis of risk-based regulatory frameworks in the European Union and Japan.
Digital health (2026)
Other Devices by A&D Company, Ltd.
Related Devices (Code: DXN)
K162092Evolv Model BP7000 Upper Arm Blood Pressure MonitorOmron Healthcare, Inc.
K161708Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd.
K162230Fully Automatic Electronic Blood Pressure MonitorAdon Health Co., Ltd.
K160349Electronic SphygmomanometerGuangdong Biolight Meditech Co., Ltd.
K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited
K161886Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure DeviceGuangdong Transtek Medical Electronics Co., Ltd.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.