510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K110501Substantially Equivalent

Hem-4030

Omron Healthcare Co., Ltd., Bonita Springs FL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110501 is the FDA 510(k) clearance record for HEM-4030, a class II device, cleared for Omron Healthcare, Inc. on under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive). FDA records list 68 510(k) clearances for Omron Healthcare, Inc., from to . As of , FDA records show no recalls naming K110501.

Clearance record

Decision date
Received
(27 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 Healthcare, Inc. 24301 Woodsage Dr., Bonita Springs FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXN

Trailing 12 months
29 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 20260