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Omron Platinum Upper Arm Blood Pressure Monitor BP5450

by Omron Healthcare, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00073796265458 UDI-DI Date1 Jul 2019ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Omron Platinum Upper Arm Blood Pressure Monitor
Generic Name
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Model / Ref / Catalog
BP5450
Description
Omron automatic digital upper arm blood pressure monitor. Two users with 100 readings of memory storage per user. Bluetooth connectivity.
Primary DI / UDI-DI
00073796265458
510(k) Number
FDA Product Code
DXN
GMDN Term
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Device Class
Class II
Regulation Number
870.1130
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Category: Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Cleared under the same submission (K133379)

Show all (12)

Other devices from Omron Healthcare, Inc.

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Properties

  • Over-the-Counter
  • Lot / Batch Number
  • Serial Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No
  • Manufacturing Date: No