510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231586Substantially Equivalent

Endophys Blood Pressure Monitor model BPM-30

Endophys Technologies, LLC, Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231586 is the FDA 510(k) clearance record for Endophys Blood Pressure Monitor model BPM-30, a class II device, cleared for Endophys Technologies, LLC on under FDA product code DSK (Computer, Blood-Pressure). FDA records list one 510(k) clearance for Endophys Technologies, LLC. As of , FDA records show no recalls naming K231586.

Clearance record

Decision date
Received
(156 days to decision)
Product code
DSK Computer, Blood-Pressure
Regulation
21 CFR 870.1110
Device class
Class II
Review panel
Cardiovascular
Applicant
Endophys Technologies, LLC 1933 E Levee St. Suite B, Dallas TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DSK

Trailing 12 months

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

FDA records show no clearances under product code DSK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DSK, 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