Cleared Traditional

K062342 - TRUEPULSE DISPOSABLE INVASIVE BLOOD PRE...

K062342 is the FDA 510(k) clearance for TRUEPULSE DISPOSABLE INVASIVE BLOOD PRE... by Sentra Medical Devices, LLC. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K062342 · Sentra Medical Devices, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
45d
Days
Class 2
Risk

K062342 is an FDA 510(k) clearance for the TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Sentra Medical Devices, LLC (Canton, US). The FDA issued a Cleared decision on September 25, 2006 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2850 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sentra Medical Devices, LLC devices

Submission Details

510(k) Number K062342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2006
Decision Date September 25, 2006
Days to Decision 45 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 125d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code DRS Transducer, Blood-pressure, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRS Transducer, Blood-pressure, Extravascular

All 71
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K062342.
Flo Trac sensor, Volume View sensor
K152980 · Edwards Lifesciences, LLC · Jan 2016
MEDLINE BLOOD PRESSURE TRANSDUCER
K123095 · Medline Industries, Inc. · May 2013
TERUMO PRESSURE ISOLATOR
K092644 · Terumo Cardiovascular Systems Corp. · Dec 2009
TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT
K061573 · Hospira, Inc. · Sep 2006
DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)
K052828 · Hospira, Inc. · Feb 2006
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P
K043065 · Edwards Lifesciences, LLC · Jan 2005