510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN230076Unknown

Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ))

Omron Healthcare Co., Ltd., Hoffman Estates IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN230076 is the FDA 510(k) clearance record for Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ)), a class II device, cleared for Omron Healthcare, Inc. on under FDA product code QXY (Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature). FDA's definition for product code QXY reads: "An oscillometric-based, over-the-counter, atrial fibrillation notification feature is a software algorithm for analysis of signals from an oscillometric, non-invasive blood pressure measurement system to screen for possible atrial...". FDA records list 68 510(k) clearances for Omron Healthcare, Inc., from to . As of , FDA records show no recalls naming DEN230076.

Clearance record

Decision date
Received
(330 days to decision)
Product code
QXY Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature
Regulation
21 CFR 870.1135
Device class
Class II
Review panel
Cardiovascular
Applicant
Omron Healthcare, Inc. 2895 Greenspoint Pkwy., Hoffman Estates IL
Third party review
No

Clearances, product code QXY

Trailing 12 months

FDA records hold no clearances under product code QXY in the trailing twelve months.

FDA records show no clearances under product code QXY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QXY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260