Cleared Traditional

K101189 - REAVILLMED PRESSURE MONITORING SYSTEM AND PICC

K101189 is an FDA 510(k) clearance for REAVILLMED PRESSURE MONITORING SYSTEM A..., manufactured by Reavillmed. The device is a Class 2 Cardiovascular device with product code DRS cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K101189 · Reavillmed · Cardiovascular device
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Dec 2010
Decision
238d
Days
Class 2
Risk

K101189 is an FDA 510(k) clearance for the REAVILLMED PRESSURE MONITORING SYSTEM AND PICC. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Reavillmed (Grayslake, US). The FDA issued a Cleared decision on December 22, 2010 after a review of 238 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Reavillmed devices

FDA 510(k) Submission Details - K101189

510(k) Number K101189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2010
Decision Date December 22, 2010
Days to Decision 238 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 125d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRS Device Classification - Class 2, Special Controls

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 104
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K101189.
ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)
K120624 · Elcam Medical Acal · Jun 2012
COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST
K112203 · Mirador Biomedical, Inc. · Dec 2011
COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE
K103715 · Mirador Biomedical, Inc. · Jan 2011
TERUMO PRESSURE ISOLATOR
K092644 · Terumo Cardiovascular Systems Corp. · Dec 2009
ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM
K070710 · Biosensors International-USA · Apr 2007
TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT
K062342 · Sentra Medical Devices, LLC · Sep 2006