Omron Digital Blood Pressure Monitor HEM-401C

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

510(k) Number

K871207 ↗

FDA Product Code

DXN

Device Class

Class II

Regulation

21 CFR Part 870.1130

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Omron Digital Blood Pressure Monitor Model HEM814F

  Class II

  FDA 510(k) K894563 Active Cleared 6 Mar 1990

• Omron Digital Fever Thermometer Model Mc-7

  Class II

  FDA 510(k) K870956 Active Cleared 16 Apr 1987

• Omron Digital Fever Thermometer Model Mc-3

  Class II

  FDA 510(k) K881415 Active Cleared 4 Oct 1988

• Omron Digital Fever Thermometer Model Mc-12B

  Class II

  FDA 510(k) K872527 Active Cleared 23 Jul 1987

• Omron Travel Massager, Model Hm-01

  Class I

  FDA 510(k) K893029 Active Cleared 31 May 1989

• Omron Digital Blood Pressure Monitor Hem-701C

  Class II

  FDA 510(k) K881269 Active Cleared 16 Jun 1988

See all devices from Omron Electronics, Inc. →

• What is the Omron Hem-401c used for?

  The Omron Hem-401c is a cardiovascular device designed to measure blood pressure in clinical or home settings, as stated in its description.

• Is the Omron Hem-401c sterile or single-use?

  The device is described as reusable and non-sterile, meaning it is intended for multiple uses after appropriate cleaning and is not provided in a sterile condition.

• How is the Omron Hem-401c supplied and by whom?

  The device is supplied by Omron Electronics, Inc., as indicated in the manufacturer and supplier information within the device data.

• What regulatory pathway was used for the Omron Hem-401c?

  The Omron Hem-401c was cleared under the FDA 510(k) process as a substantially equivalent device, based on the decision description and clearance type in the specifications.