510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K040002Substantially Equivalent

Microlife Wrist Watch Blood Pressure Monitor, Model Bp3ax1

Microlife Intellectual Property Gmb, Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040002 is the FDA 510(k) clearance record for MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1, a class II device, cleared for Microlife Intellectual Property Gmb on under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive). FDA records list one 510(k) clearance for Microlife Intellectual Property Gmb. As of , FDA records show no recalls naming K040002.

Clearance record

Decision date
Received
(80 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
Microlife Intellectual Property Gmb 55 Northern Blvd., Suite 200, Great Neck NY
510(k) summary
Summary PDF
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