Cleared Traditional

K092644 - TERUMO PRESSURE ISOLATOR

K092644 is an FDA 510(k) clearance for TERUMO PRESSURE ISOLATOR, manufactured by Terumo Cardiovascular Systems Corp.. The device is a Class 2 Cardiovascular device with product code DRS cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K092644 · Terumo Cardiovascular Systems Corp. · Cardiovascular device
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Dec 2009
Decision
105d
Days
Class 2
Risk

K092644 is an FDA 510(k) clearance for the TERUMO PRESSURE ISOLATOR. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems Corp. (Elkton, US). The FDA issued a Cleared decision on December 10, 2009 after a review of 105 days - within the typical 510(k) review window.

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 Terumo Cardiovascular Systems Corp. devices

FDA 510(k) Submission Details - K092644

510(k) Number K092644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2009
Decision Date December 10, 2009
Days to Decision 105 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 125d · This submission: 105d
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 87
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K092644.
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
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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