510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K994423Substantially Equivalent

Automated Non-Invasive Blood Pressure Monitor, Model Bpm-100

Vsm Medtech, Ltd., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994423 is the FDA 510(k) clearance record for AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100, a class II device, cleared for Vsm Medtech , Ltd. on under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive). FDA records list 3 510(k) clearances for Vsm Medtech , Ltd., from to . As of , FDA records show no recalls naming K994423.

Clearance record

Decision date
Received
(90 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
Vsm Medtech , Ltd. 555 13th St., NW, Washington DC
510(k) summary
Statement
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