Cleared Traditional

K133624 - COMPASS CT, COMPASS CT PORT

K133624 is an FDA 510(k) clearance for COMPASS CT, manufactured by Mirador Biomedical. The device is a Class 2 Cardiovascular device with product code DRS cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K133624 · Mirador Biomedical · Cardiovascular device
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Apr 2014
Decision
143d
Days
Class 2
Risk

K133624 is an FDA 510(k) clearance for the COMPASS CT, COMPASS CT PORT. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Mirador Biomedical (Seattle, US). The FDA issued a Cleared decision on April 18, 2014 after a review of 143 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 Mirador Biomedical devices

FDA 510(k) Submission Details - K133624

510(k) Number K133624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2013
Decision Date April 18, 2014
Days to Decision 143 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 125d · This submission: 143d
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 101
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K133624.
Disposable Pressure Transducer
K152472 · Zhejiang Haisheng Medical Device Co., Ltd. · Oct 2016
Flo Trac sensor, Volume View sensor
K152980 · Edwards Lifesciences, LLC · Jan 2016
Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer
K151040 · Biometrix , Ltd. · Sep 2015
MEDLINE BLOOD PRESSURE TRANSDUCER
K123095 · Medline Industries, Inc. · May 2013
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