510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K062342Substantially Equivalent

Truepulse Disposable Invasive Blood Pressure Monitoring Kit

Sentra Medical Devices, LLC, Canton MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062342 is the FDA 510(k) clearance record for TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT, a class II device, cleared for Sentra Medical Devices, LLC on under FDA product code DRS (Transducer, Blood-Pressure, Extravascular). FDA records list one 510(k) clearance for Sentra Medical Devices, LLC. As of , FDA records show no recalls naming K062342.

Clearance record

Decision date
Received
(45 days to decision)
Product code
DRS Transducer, Blood-Pressure, Extravascular
Regulation
21 CFR 870.2850
Device class
Class II
Review panel
Cardiovascular
Applicant
Sentra Medical Devices, LLC 2831 Woodmont Dr. W, Canton MI
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code DRS

Trailing 12 months
1 clearance under product code DRS in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRS, 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 20261
October 20260