510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K903133Substantially Equivalent

Omron Oscillometric Digital Bp Monitor-Hem-405C

Omron Marshall Products, Inc., Lincolnshire IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903133 is the FDA 510(k) clearance record for OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C, a class II device, cleared for Omron Marshall Products, Inc. on under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive). FDA records list 3 510(k) clearances for Omron Marshall Products, Inc., from to . As of , FDA records show no recalls naming K903133.

Clearance record

Decision date
Received
(185 days to decision)
Product code
DXN System, Measurement, Blood-Pressure, Non-Invasive
Regulation
21 CFR 870.1130
Device class
Class II
Review panel
Cardiovascular
Applicant
Omron Marshall Products, Inc. 600 Barclay Blvd., Lincolnshire IL
Third party review
No

Clearances, product code DXN

Trailing 12 months
30 clearances under product code DXN in the twelve months to October 2026, April 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DXN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20262
February 20264
March 20262
April 20265
May 20263
June 20264
July 20262
August 20264
September 20262
October 20261