BPCard

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K031964 ↗

FDA Product Code

DXN

Device Class

Class II

Regulation

21 CFR Part 870.1130

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modification to: Bpcard, Model Z-7000-0700

  Class II

  FDA 510(k) K073630 Active Cleared 11 Jan 2008

• Spiroxcard Diagnostic Spirometer and Pulse Oximeter

  Class II

  FDA 510(k) K001995 Active Cleared 8 Sep 2000

• Sensaire Diagnostic Spirometer

  Class II

  FDA 510(k) K001278 Active Cleared 29 Nov 2000

• CARDIOVIEW32 Review Module

  Not classified

  FDA 510(k) K083749 Active Cleared 10 Mar 2009

• Ekgcard System

  Class II

  FDA 510(k) K030535 Active Cleared 11 Jun 2003

• SpiroCard

  Class II

  FDA 510(k) K973138 Active Cleared 28 Oct 1998

• What types of patients is the BPCard designed to measure blood pressure for?

  The BPCard is designed specifically for adult male and female subjects to measure systolic and diastolic blood pressure using the auscultatory method. It is not indicated for pediatric or neonatal use, as the data does not mention these populations.

• Is the BPCard intended for single-use or reusable applications in a clinical setting?

  The BPCard is supplied as a reusable medical instrument, meaning it is meant for repeated use within regulated healthcare settings. The data explicitly states no third-party reprocessing is indicated, so it should only be cleaned and maintained by the facility where it is used.

• How is the BPCard regulated, and what pathway was used for its FDA clearance?

  The BPCard received FDA clearance under the Traditional review pathway through a 510(k) submission (K031964). It is classified under the product code DXN (Non-Invasive Blood Pressure Measurement Systems) and adheres to standards reviewed by the Cardiovascular Advisory Committee.

• Does the BPCard measure anything beyond blood pressure, and if so, what?

  Yes, in addition to measuring systolic and diastolic blood pressure using the auscultatory method, the BPCard also provides heart rate monitoring for adult patients. This dual functionality is explicitly mentioned in the device description.

• What kind of healthcare settings is the BPCard intended for, and does it require special handling like MRI safety or sterility?

  The BPCard is intended for clinical use in regulated healthcare settings, such as hospitals or clinics. The data does not specify MRI safety or sterility requirements, so it should be handled according to standard reusable medical instrument protocols—no special MRI precautions or sterilization are indicated.